Regulatory Affair Professional

3 weeks ago


Penang, Malaysia Ambu AS Full time

Ambu Global Hub is currently looking for a Regulatory Affair Professional for our Global Emerging Market (GEM) team to be based in Penang, Malaysia. This role is responsible for Regulatory Affairs & Quality Assurance.

This position reports to the Regional Commercial RA Manager. If you are from the medical device industry with experience in regulatory affairs, this position would be suitable for you.

Key Responsibilities
  1. Regulatory Affairs
  2. Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners/distributors.
  3. Timely compile materials for license renewals, updates, and registrations.
  4. Maintain regulatory files/database and chronologies in good order. Establish and maintain a system for tracking changes in documents submitted to agencies or distributors.
  5. Review labeling and labels for compliance with regulatory requirements.
  6. Review changes to existing products and SOPs to define the requirements for regulatory submissions.
  7. Provide the regulatory reviews of customer complaints and define the regulatory reportability; manage vigilance reporting communication within GEM territory specifically in Eastern Europe, Middle East & Africa (EEMEA).
  8. Maintain current knowledge of applicable regional regulation, guidance, and standards applicable to company products.
  9. Other duties as assigned.
  1. Quality Assurance
  2. Responsible for specific distributor requirements within GEM territory specifically in EEMEA including ensuring establishment and maintenance of Distributor Quality Agreements.
  3. Note: Territory of responsibility is EEMEA, however, there may be times when the employee is asked to cover/assist other GEM colleagues with regulatory duties within their geographical areas of responsibility.
Suggested Candidate Profile
  1. A minimum education in Bachelor's degree or professional qualification, preferably with a major in Life Science, Pharmacy, Biotechnology or any related technical field.
  2. An established candidate with 5-6 years' experience in Regulatory Affairs/Medical Device industry.
  3. Quality assurance experience in the medical industry would be an advantage.
  4. Can work independently with minimum supervision.

Ambu – a visionary and international workplace where your efforts matter.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social, and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety, and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America, and the Asia Pacific.

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