55 Regulatory Affairs Specialist jobs in Malaysia

Regulatory Affairs Specialist

Kulim, Kedah BD (Becton, Dickinson and Company)

Posted 10 days ago

Job Viewed

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Job Description

**Job Description Summary**
**Job Description**
P3-14314
Required Skills
Optional Skills
.
**Primary Work Location**
MYS Kedah - Bard Kulim (Malaysia)
**Additional Locations**
**Work Shift**
MY3 Normal 8a-4.45p Group 26 (Malaysia)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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Scientific & Regulatory Affairs Specialist

JACOBS DOUWE EGBERTS

Posted 4 days ago

Job Viewed

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Job Description

Scientific & Regulatory Affairs Specialist R&D Masai Full-time Malaysia Job Description

Key Responsibilities/ Key Activities:

  • Regularly prepares, approves and issues labelling specifications to meet business needs and timelines for the local and foreign markets by following and using effectively JDE & SARA agreed processes and tools.
  • Conducts accurate label compliance reviews, such as proposing legal designations and acceptable claims wording, considering local Business requests and legal feedback.
  • Provides legal and accurate ingredients line and nutrition data for food product labels.
  • Assures implementation of correct graphic design, and able to advise and guide team members on artwork design elements.
  • Assures implementation of correct techno-legal label information and JDE standards, e.g. allergen labelling and claims.
  • Provides regulatory guidance on compositional requirements to R&D, e.g. checks for acceptable ingredients and their legal limits in recipes.
  • Timely reviews and approves new raw materials and product specifications for regulatory compliance in local and other countries, including checking product recipes, nutrition data and allergens information.
  • Create and review product specifications based on internal specification guidelines.
  • Represents JDE as an expert on local industry associations, scientific institutions and governmental bodies in collaboration with SARA team leads and/or R&D Lead. Identifies, Head of Department and stays abreast of emerging scientific issues and legislation changes.
  • Interacts regularly with the other R&D team members, and in particular functional manager, on weekly deliverables.
Qualifications

Are you bursting with fresh ideas and a hunger for learning? We want you!

Here's what we're looking for:

  • Academic Program : Degree or Master in Nutrition, Food Chemistry, Food Technology, Food Science or equivalent.
  • Experienced : Minimum at 3 to 5 years’ experience in related field.
  • Skillset : Possess Knowledge of (EU) food legislation, understanding of nutrition science and food safety, product development, ingredients, manufacturing and business processes.
  • Personal traits : You have a structured approach, a driven and energetic personality, excellent communication and people skills, and the ability to work both in a team and independently.
Additional Information

Here's how to apply:

  • Upload your resume (in English) using our LinkedIn or career site application form
  • After applying, we'll reach out within three weeks to let you know what's next.
  • During the application process, you'll be asked to do an online assessment and at least one interview at our Johor office.
Company Description

For more than 265 years, JACOBS DOUWE EGBERTS (JDE) is inspired by its belief that it’s amazing what can happen over a cup of coffee or tea. We are fuelled by our purpose of unleashing the possibilities of coffee and tea to create a better future. Today, our coffee & tea portfolio is available in more than 100 developed and emerging markets, through a portfolio of over 50 brands that collectively cover the entire category landscape led by leading household names such as L’OR, Jacobs, Senseo, Tassimo, Douwe Egberts, Old Town, Super, Pickwick and Moccona.

JDE is part of JDE Peet’s, the world’s largest pure-play coffee and tea company, headquartered in The Netherlands.

What’s it like to work at JDE?

We are proud of our passionate, driven associates that challenge the status quo and pursue mastery in everything they do. Our goal is simple and ambitious – JDE: A coffee & tea for every cup.

At JDE, we're Made to Stand Out. Every day we are progressive in outlook, ambitious in nature, resourceful in action and decisive in approach, bringing coffee and tea moments to everyone around the world.

#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.

Scientific & Regulatory Affairs Specialist

Jdeprofessional

Posted 4 days ago

Job Viewed

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Job Description

Scientific & Regulatory Affairs Specialist R&D Masai Full-time Malaysia Job Description

Key Responsibilities/ Key Activities:

  • Regularly prepares, approves and issues labelling specifications to meet business needs and timelines for the local and foreign markets by following and using effectively JDE & SARA agreed processes and tools.
  • Conducts accurate label compliance reviews, such as proposing legal designations and acceptable claims wording, considering local Business requests and legal feedback.
  • Provides legal and accurate ingredients line and nutrition data for food product labels.
  • Assures implementation of correct graphic design, and able to advise and guide team members on artwork design elements.
  • Assures implementation of correct techno-legal label information and JDE standards, e.g. allergen labelling and claims.
  • Provides regulatory guidance on compositional requirements to R&D, e.g. checks for acceptable ingredients and their legal limits in recipes.
  • Timely reviews and approves new raw materials and product specifications for regulatory compliance in local and other countries, including checking product recipes, nutrition data and allergens information.
  • Create and review product specifications based on internal specification guidelines.
  • Represents JDE as an expert on local industry associations, scientific institutions and governmental bodies in collaboration with SARA team leads and/or R&D Lead. Identifies, Head of Department and stays abreast of emerging scientific issues and legislation changes.
  • Interacts regularly with the other R&D team members, and in particular functional manager, on weekly deliverables.
Qualifications

Are you bursting with fresh ideas and a hunger for learning? We want you!

Here's what we're looking for:

  • Academic Program : Degree or Master in Nutrition, Food Chemistry, Food Technology, Food Science or equivalent.
  • Experienced : Minimum at 3 to 5 years’ experience in related field.
  • Skillset : Possess Knowledge of (EU) food legislation, understanding of nutrition science and food safety, product development, ingredients, manufacturing and business processes.
  • Personal traits : You have a structured approach, a driven and energetic personality, excellent communication and people skills, and the ability to work both in a team and independently.
Additional Information

Are you ready to Unleash Your Possibility within JDE Peet's?

Here's how to apply:

  • Upload your resume (in English) using our LinkedIn or career site application form.
  • After applying, we'll reach out within three weeks to let you know what's next.
  • During the application process, you'll be asked to do an online assessment and at least one interview at our Johor office.

Would you like to join a Coffee & Tea company that values your future success and prioritizes your passion for positive change?

Here’s why you should apply:

  • Passionate, energetic & innovative work culture.
  • Exciting allowances to perk up your day.
  • Sports perks to keep you energized.
  • The best coffee and tea served all day in our office – or be your own Barista!
Company Description

For more than 265 years, JACOBS DOUWE EGBERTS (JDE) is inspired by its belief that it’s amazing what can happen over a cup of coffee or tea. We are fuelled by our purpose of unleashing the possibilities of coffee and tea to create a better future. Today, our coffee & tea portfolio is available in more than 100 developed and emerging markets, through a portfolio of over 50 brands that collectively cover the entire category landscape led by leading household names such as L’OR, Jacobs, Senseo, Tassimo, Douwe Egberts, Old Town, Super, Pickwick and Moccona.

JDE is part of JDE Peet’s, the world’s largest pure-play coffee and tea company, headquartered in The Netherlands.

What’s it like to work at JDE?

We are proud of our passionate, driven associates that challenge the status quo and pursue mastery in everything they do. Our goal is simple and ambitious – JDE: A coffee & tea for every cup.

At JDE, we're Made to Stand Out. Every day we are progressive in outlook, ambitious in nature, resourceful in action and decisive in approach, bringing coffee and tea moments to everyone around the world.

#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.

Scientific & Regulatory Affairs Specialist

Kelantan, Kelantan JACOBS DOUWE EGBERTS

Posted 14 days ago

Job Viewed

Tap Again To Close

Job Description

Scientific & Regulatory Affairs Specialist

R&D Masai Full-time Malaysia

Job Description

Key Responsibilities/ Key Activities: Regularly prepares, approves and issues labelling specifications to meet business needs and timelines for the local and foreign markets by following and using effectively JDE & SARA agreed processes and tools. Conducts accurate label compliance reviews, such as proposing legal designations and acceptable claims wording, considering local Business requests and legal feedback. Provides legal and accurate ingredients line and nutrition data for food product labels. Assures implementation of correct graphic design, and able to advise and guide team members on artwork design elements. Assures implementation of correct techno-legal label information and JDE standards, e.g. allergen labelling and claims. Provides regulatory guidance on compositional requirements to R&D, e.g. checks for acceptable ingredients and their legal limits in recipes. Timely reviews and approves new raw materials and product specifications for regulatory compliance in local and other countries, including checking product recipes, nutrition data and allergens information. Create and review product specifications based on internal specification guidelines. Represents JDE as an expert on local industry associations, scientific institutions and governmental bodies in collaboration with SARA team leads and/or R&D Lead. Identifies, Head of Department and stays abreast of emerging scientific issues and legislation changes. Interacts regularly with the other R&D team members, and in particular functional manager, on weekly deliverables. Qualifications

Are you bursting with fresh ideas and a hunger for learning? We want you! Here's what we're looking for: Academic Program : Degree or Master in Nutrition, Food Chemistry, Food Technology, Food Science or equivalent. Experienced : Minimum at 3 to 5 years’ experience in related field. Skillset : Possess Knowledge of (EU) food legislation, understanding of nutrition science and food safety, product development, ingredients, manufacturing and business processes. Personal traits : You have a structured approach, a driven and energetic personality, excellent communication and people skills, and the ability to work both in a team and independently. Additional Information

Here's how to apply: Upload your resume (in English) using our LinkedIn or career site application form After applying, we'll reach out within three weeks to let you know what's next. During the application process, you'll be asked to do an online assessment and at least one interview at our Johor office. Company Description

For more than 265 years, JACOBS DOUWE EGBERTS (JDE) is inspired by its belief that it’s amazing what can happen over a cup of coffee or tea. We are fuelled by our purpose of unleashing the possibilities of coffee and tea to create a better future. Today, our coffee & tea portfolio is available in more than 100 developed and emerging markets, through a portfolio of over 50 brands that collectively cover the entire category landscape led by leading household names such as L’OR, Jacobs, Senseo, Tassimo, Douwe Egberts, Old Town, Super, Pickwick and Moccona. JDE is part of JDE Peet’s, the world’s largest pure-play coffee and tea company, headquartered in The Netherlands. What’s it like to work at JDE? We are proud of our passionate, driven associates that challenge the status quo and pursue mastery in everything they do. Our goal is simple and ambitious – JDE: A coffee & tea for every cup. At JDE, we're Made to Stand Out. Every day we are progressive in outlook, ambitious in nature, resourceful in action and decisive in approach, bringing coffee and tea moments to everyone around the world.

#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.

Scientific & Regulatory Affairs Specialist

Kelantan, Kelantan Jdeprofessional

Posted 14 days ago

Job Viewed

Tap Again To Close

Job Description

Scientific & Regulatory Affairs Specialist

R&D Masai Full-time Malaysia

Job Description

Key Responsibilities/ Key Activities: Regularly prepares, approves and issues labelling specifications to meet business needs and timelines for the local and foreign markets by following and using effectively JDE & SARA agreed processes and tools. Conducts accurate label compliance reviews, such as proposing legal designations and acceptable claims wording, considering local Business requests and legal feedback. Provides legal and accurate ingredients line and nutrition data for food product labels. Assures implementation of correct graphic design, and able to advise and guide team members on artwork design elements. Assures implementation of correct techno-legal label information and JDE standards, e.g. allergen labelling and claims. Provides regulatory guidance on compositional requirements to R&D, e.g. checks for acceptable ingredients and their legal limits in recipes. Timely reviews and approves new raw materials and product specifications for regulatory compliance in local and other countries, including checking product recipes, nutrition data and allergens information. Create and review product specifications based on internal specification guidelines. Represents JDE as an expert on local industry associations, scientific institutions and governmental bodies in collaboration with SARA team leads and/or R&D Lead. Identifies, Head of Department and stays abreast of emerging scientific issues and legislation changes. Interacts regularly with the other R&D team members, and in particular functional manager, on weekly deliverables. Qualifications

Are you bursting with fresh ideas and a hunger for learning? We want you! Here's what we're looking for: Academic Program : Degree or Master in Nutrition, Food Chemistry, Food Technology, Food Science or equivalent. Experienced : Minimum at 3 to 5 years’ experience in related field. Skillset : Possess Knowledge of (EU) food legislation, understanding of nutrition science and food safety, product development, ingredients, manufacturing and business processes. Personal traits : You have a structured approach, a driven and energetic personality, excellent communication and people skills, and the ability to work both in a team and independently. Additional Information

Are you ready to

Unleash Your Possibility

within JDE Peet's? Here's how to apply: Upload your resume (in English) using our LinkedIn or career site application form. After applying, we'll reach out within three weeks to let you know what's next. During the application process, you'll be asked to do an online assessment and at least one interview at our Johor office. Would you like to join a Coffee & Tea company that values your future success and prioritizes your passion for positive change? Here’s why you should apply: Passionate, energetic & innovative work culture. Exciting allowances to perk up your day. Sports perks to keep you energized. The best coffee and tea served all day in our office – or be your own Barista! Company Description

For more than 265 years, JACOBS DOUWE EGBERTS (JDE) is inspired by its belief that it’s amazing what can happen over a cup of coffee or tea. We are fuelled by our purpose of unleashing the possibilities of coffee and tea to create a better future. Today, our coffee & tea portfolio is available in more than 100 developed and emerging markets, through a portfolio of over 50 brands that collectively cover the entire category landscape led by leading household names such as L’OR, Jacobs, Senseo, Tassimo, Douwe Egberts, Old Town, Super, Pickwick and Moccona. JDE is part of JDE Peet’s, the world’s largest pure-play coffee and tea company, headquartered in The Netherlands. What’s it like to work at JDE? We are proud of our passionate, driven associates that challenge the status quo and pursue mastery in everything they do. Our goal is simple and ambitious – JDE: A coffee & tea for every cup. At JDE, we're Made to Stand Out. Every day we are progressive in outlook, ambitious in nature, resourceful in action and decisive in approach, bringing coffee and tea moments to everyone around the world.

#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.

Senior Regulatory Affairs Specialist, APAC

ZOLL Medical Corporation

Posted 2 days ago

Job Viewed

Tap Again To Close

Job Description

Senior Regulatory Affairs Specialist, APAC

Acute Care TechnologyJob Summary:
This position will report to the Senior Manager, Regulatory Affairs Regional Leader, JAPAC. The Primary role of the Specialist within the company is to assist Regulatory Affairs department to implement and administrate of organization activities to support and ensure regulatory compliance.

At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

At ZOLL, you won’t just have a job. You'll have a career—and a purpose.

Join our team. It’s a great time to be a part of ZOLL!

The Regulatory Affairs Specialist plays a key role in supporting the Regulatory Affairs department by implementing and managing organizational activities to ensure regulatory compliance across key global markets, with a focus on the APAC region.

Essential Functions:

  • Maintain working knowledge of APAC medical regulations, as well as FDA and European Medical Device Regulations (MDR); familiarity with ISO 13485 is a plus

  • Participate in cross-functional product core teams to ensure compliance with internal policies and external regulatory requirements

  • Develop, document, and implement regulatory strategy plans aligned with product development objectives

  • Prepare technical dossiers and regulatory submissions for target markets

  • Draft and submit responses to regulatory agencies with clear, concise, and well-structured communication

  • Assess the regulatory impact of product and process changes in accordance with APAC regulations and standards

  • Implement and maintain standardized submission templates and documentation

  • Maintain regulatory files and product licenses in a well-organized and up-to-date manner

  • Stay current with global medical device regulations, guidance, and standards; analyze updates and communicate key changes to relevant stakeholders

  • Participate in continuous improvement activities within the department, and propose process enhancements to improve submission efficiency and accuracy

  • Support device recall activities as needed

  • Participate in internal audit activities as an auditor

Required Education and Experience:

  • Bachelor’s degree in a relevant field

  • 3 to 5 years of regulatory affairs experience, preferably in the healthcare or medical device industry

Key Skills and Attributes:

  • Strong organizational and time-management skills

  • Ability to work independently and collaboratively in a team environment

  • Detail-oriented, responsible, and proactive

  • Able to perform under pressure and meet deadlines

  • Strong written and verbal communication skills


ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.

Senior Regulatory Affairs Specialist, APAC

Selangor, Selangor ZOLL Medical Corporation

Posted 4 days ago

Job Viewed

Tap Again To Close

Job Description

Senior Regulatory Affairs Specialist, APAC page is loadedSenior Regulatory Affairs Specialist, APAC Apply remote type Hybrid locations Selangor, Malaysia posted on Posted Yesterday job requisition id R15695 Acute Care TechnologyJob Summary:
This position will report to the Senior Manager, Regulatory Affairs Regional Leader, JAPAC. The Primary role of the Specialist within the company is to assist Regulatory Affairs department to implement and administrate of organization activities to support and ensure regulatory compliance.

At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

At ZOLL, you won’t just have a job. You'll have a career—and a purpose.

Join our team. It’s a great time to be a part of ZOLL!

The Regulatory Affairs Specialist plays a key role in supporting the Regulatory Affairs department by implementing and managing organizational activities to ensure regulatory compliance across key global markets, with a focus on the APAC region.

Essential Functions:

  • Maintain working knowledge of APAC medical regulations, as well as FDA and European Medical Device Regulations (MDR); familiarity with ISO 13485 is a plus

  • Participate in cross-functional product core teams to ensure compliance with internal policies and external regulatory requirements

  • Develop, document, and implement regulatory strategy plans aligned with product development objectives

  • Prepare technical dossiers and regulatory submissions for target markets

  • Draft and submit responses to regulatory agencies with clear, concise, and well-structured communication

  • Assess the regulatory impact of product and process changes in accordance with APAC regulations and standards

  • Implement and maintain standardized submission templates and documentation

  • Maintain regulatory files and product licenses in a well-organized and up-to-date manner

  • Stay current with global medical device regulations, guidance, and standards; analyze updates and communicate key changes to relevant stakeholders

  • Participate in continuous improvement activities within the department, and propose process enhancements to improve submission efficiency and accuracy

  • Support device recall activities as needed

  • Participate in internal audit activities as an auditor

Required Education and Experience:

  • Bachelor’s degree in a relevant field

  • 3 to 5 years of regulatory affairs experience, preferably in the healthcare or medical device industry

Key Skills and Attributes:

  • Strong organizational and time-management skills

  • Ability to work independently and collaboratively in a team environment

  • Detail-oriented, responsible, and proactive

  • Able to perform under pressure and meet deadlines

  • Strong written and verbal communication skills


ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

About Us

ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. For more information, visit

The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit

#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.
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Senior Regulatory Affairs Specialist, APAC

Kelantan, Kelantan ZOLL Medical Corporation

Posted 14 days ago

Job Viewed

Tap Again To Close

Job Description

Senior Regulatory Affairs Specialist, APAC

Acute Care TechnologyJob Summary: This position will report to the Senior Manager, Regulatory Affairs Regional Leader, JAPAC. The Primary role of the Specialist within the company is to assist Regulatory Affairs department to implement and administrate of organization activities to support and ensure regulatory compliance. At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

At ZOLL, you won’t just have a job. You'll have a career—and a purpose.

Join our team. It’s a great time to be a part of ZOLL! The Regulatory Affairs Specialist plays a key role in supporting the Regulatory Affairs department by implementing and managing organizational activities to ensure regulatory compliance across key global markets, with a focus on the APAC region. Essential Functions: Maintain working knowledge of APAC medical regulations, as well as FDA and European Medical Device Regulations (MDR); familiarity with ISO 13485 is a plus

Participate in cross-functional product core teams to ensure compliance with internal policies and external regulatory requirements

Develop, document, and implement regulatory strategy plans aligned with product development objectives

Prepare technical dossiers and regulatory submissions for target markets

Draft and submit responses to regulatory agencies with clear, concise, and well-structured communication

Assess the regulatory impact of product and process changes in accordance with APAC regulations and standards

Implement and maintain standardized submission templates and documentation

Maintain regulatory files and product licenses in a well-organized and up-to-date manner

Stay current with global medical device regulations, guidance, and standards; analyze updates and communicate key changes to relevant stakeholders

Participate in continuous improvement activities within the department, and propose process enhancements to improve submission efficiency and accuracy

Support device recall activities as needed

Participate in internal audit activities as an auditor

Required Education and Experience: Bachelor’s degree in a relevant field

3 to 5 years of regulatory affairs experience, preferably in the healthcare or medical device industry

Key Skills and Attributes: Strong organizational and time-management skills

Ability to work independently and collaboratively in a team environment

Detail-oriented, responsible, and proactive

Able to perform under pressure and meet deadlines

Strong written and verbal communication skills

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.

Senior Regulatory Affairs Specialist, APAC

Klang, Selangor ZOLL Medical Corporation

Posted 14 days ago

Job Viewed

Tap Again To Close

Job Description

Senior Regulatory Affairs Specialist, APAC page is loaded Senior Regulatory Affairs Specialist, APAC Apply remote type Hybrid locations Selangor, Malaysia posted on Posted Yesterday job requisition id R15695 Acute Care TechnologyJob Summary: This position will report to the Senior Manager, Regulatory Affairs Regional Leader, JAPAC. The Primary role of the Specialist within the company is to assist Regulatory Affairs department to implement and administrate of organization activities to support and ensure regulatory compliance. At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

At ZOLL, you won’t just have a job. You'll have a career—and a purpose.

Join our team. It’s a great time to be a part of ZOLL! The Regulatory Affairs Specialist plays a key role in supporting the Regulatory Affairs department by implementing and managing organizational activities to ensure regulatory compliance across key global markets, with a focus on the APAC region. Essential Functions: Maintain working knowledge of APAC medical regulations, as well as FDA and European Medical Device Regulations (MDR); familiarity with ISO 13485 is a plus

Participate in cross-functional product core teams to ensure compliance with internal policies and external regulatory requirements

Develop, document, and implement regulatory strategy plans aligned with product development objectives

Prepare technical dossiers and regulatory submissions for target markets

Draft and submit responses to regulatory agencies with clear, concise, and well-structured communication

Assess the regulatory impact of product and process changes in accordance with APAC regulations and standards

Implement and maintain standardized submission templates and documentation

Maintain regulatory files and product licenses in a well-organized and up-to-date manner

Stay current with global medical device regulations, guidance, and standards; analyze updates and communicate key changes to relevant stakeholders

Participate in continuous improvement activities within the department, and propose process enhancements to improve submission efficiency and accuracy

Support device recall activities as needed

Participate in internal audit activities as an auditor

Required Education and Experience: Bachelor’s degree in a relevant field

3 to 5 years of regulatory affairs experience, preferably in the healthcare or medical device industry

Key Skills and Attributes: Strong organizational and time-management skills

Ability to work independently and collaboratively in a team environment

Detail-oriented, responsible, and proactive

Able to perform under pressure and meet deadlines

Strong written and verbal communication skills

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

About Us

ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. For more information, visit The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit
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Scientific & Regulatory Affairs (SARA) Specialist

Johor Bahru, Johor JACOBS DOUWE EGBERTS

Posted 3 days ago

Job Viewed

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Job Description

Scientific & Regulatory Affairs (SARA) Specialist Job Description

Responsibilities/ Key Activities:

Regulatory Affairs

  • Accountable to monitor the new / changes in South East Asia Regulatory requirements (including industry trends & practices), inform Internal Stakeholders and adapt Regulatory strategies accordingly and timely.
  • Represents JDE as an Expert on respective Local Industry Associations, Scientific Institutions and Government bodies in collaboration with SARA Team Leads and/or R&D Lead.
  • Stay abreast of emerging scientific issues and legislation changes.

Regulatory Compliance

  • Regularly prepares, approves and issues labelling specifications to meet business needs and timelines for the local and foreign markets by following and using effectively JDE & SARA agreed processes and tools.
  • Conducts accurate label compliance reviews, such as proposing legal designations and acceptable claims wording, considering local Business requests and Legal feedback.
  • Provides legal and accurate ingredients line and nutrition data for food product labels.
  • Assures implementation of correct graphic design, and able to advise and guide team members on artwork design elements via CopyDeck and Syncforce processes.
  • Assures implementation of correct techno-legal label information and JDE standards, e.g. allergen labelling and claims.
  • Provides regulatory guidance on compositional requirements to R&D, e.g. checks for acceptable ingredients and their legal limits in recipes.
  • Timely reviews and approves new raw materials and product specifications for regulatory compliance in local and other countries, including checking product recipes, nutrition data, allergens information and promotional materials to ensure compliance with local regulations and company standards.
  • When Halal is concern, able to provide compliance guidance to the Stakeholders.

Regulatory Submissions

  • Support the Supply Chain Team in preparing the regulatory documents, including for product registrations, variations, renewals and responses to regulatory queries, in accordance with local requirements.

Scientific Support

  • Provide scientific expertise and support to cross functional teams in areas such as Product Development, Market Research, Quality, Operations and Customer Experience.

Training and Education

  • Conduct training sessions and provide educational materials to internal stakeholders to enhance understanding of Regulatory requirements and promote compliance culture.

Cross-Functional Collaboration

  • Collaborate closely with internal teams, including R&D Product Team, Packaging & D2P, Regional Quality & Food Safety, Marketing, and Legal, to facilitate regulatory compliance and achieve business objectives, regularly.
Qualifications

Education :

Bachelor’s Degree / Master’s Degree in Nutrition, Food Chemistry, Food Technology, Food Science or equivalent.

Experience & Competencies:

  • At least 3 to 5 years’ experience in Regulatory Affairs within food industry of South East Asia market, preferably coffee & tea industry.
  • Thorough understanding of local Regulatory Affairs requirements and processes related to food legislation.
  • Considerable understanding of nutrition science and food safety
  • Understanding of product development, ingredients, manufacturing and business processes.
  • Good articulation and networking with respective Local Industry Associations, Scientific Institutions and Government/Authority bodies
  • Ability to manage and prioritize multiple time-constrained tasks
  • System acumen and IT skills.
  • Excellent communication in English and Malay with multilingual ability, both written and verbal.
  • Proven ability to manage multiple projects simultaneously and meet tight deadlines (Project Management Skills).
  • Strong interpersonal skills with the ability to collaborate effectively across cross-functional teams.
Additional Information

Are you ready to Unleash Your Possibility within JDE Peet's?

Here's how to apply:

  • Upload your resume (in English) using our LinkedIn or career site application form
  • After applying, we'll reach out within three weeks to let you know what's next.
  • During the application process, you'll be asked to do an online assessment and at least one interview at our Johoroffice.

Would you like to join an internship at a Coffee & Tea company that values your future success and prioritizes your passion for positive change?

Here’s why you should apply:

  • Passionate, energetic & innovative work culture
  • Exciting allowances to perk up your day
  • Sports perks to keep you energized
  • The best coffee and tea served all day in our office – or be your own Barista!
Company Description

Company Description

It’s amazing what can happen over a cup of coffee. At JACOBS DOUWE EGBERTS (JDE) , we’ve made it our mission to find out. Our people have been raising the bar since day one, thinking fast and acting even faster to make an impact that’s felt around the world. JDE is the home to some of the most well-known coffee brands in the world.

For more than 265 years, we have been inspired by the belief. Today our coffee & tea portfolio is available in over 140 countries around the world through iconic household names including: Jacobs, Tassimo, Moccona, Senseo, L’OR, Douwe Egberts, Super, Kenco, Pilao & Gevalia etc.

It’s amazing what can happen over a cup of coffee. At JACOBS DOUWE EGBERTS (JDE) , we’ve made it our mission to find out. Our people have been raising the bar since day one, thinking fast and acting even faster to make an impact that’s felt around the world. JDE is the home to some of the most well-known coffee brands in the world.

For more than 265 years, we have been inspired by the belief. Today our coffee & tea portfolio is available in over 140 countries around the world through iconic household names including: Jacobs, Tassimo, Moccona, Senseo, L’OR, Douwe Egberts, Super, Kenco, Pilao & Gevalia etc.

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