Job Description
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Senior Regulatory Affairs Executive
City:  Penang
State: 
Country:  Malaysia
Business Area:  Quality Assurance
Department:  RA, Penang
Employment Type:  Full-time

Reponsibilities:

  • Involve in Innovation projects - Advise project team on regulatory aspects and changes that would affect product manufactured.
  • Prepare product technical documentation.
  • Involve in product registration - Prepare product registration documents for the requested countries, work with regulatory body/ agency on required document for registration submission.
  • To apply Free Sale Certificate & Manufacturing Certificate and arrange for legalization of certificates.
  • Work with HQ on regulatory documents and release order.
  • Support marketing on label changes and marketing material review.
  • Other regulatory task as assigned.

 

Requirements:

  • Degree in Science or Engineering.
  • Preferable with minimum 3 year's working experience in Regulatory Affairs.
  • Knowledge of ISO 13485.
  • Knowledge of regulatory and registration document submission in ROW.
  • Personal - Committed with positive attitude, flexible, good accountability and good team spirit.

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.

For more information, please visit ambu.com or follow us on LinkedIn.
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