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Global Compliance Manager

2 weeks ago

Penang, Malaysia Ambu AS Full time
About the Role

The successful candidate will play a crucial role in maintaining Ambu's compliance with regional regulations and standards, ensuring the quality and safety of our products.

This is an exciting opportunity for a highly motivated individual to join our Global Emerging Market (GEM) team based in Penang, Malaysia.

Main Responsibilities
  1. Regulatory Affairs
  • Manage the preparation and submission of regulatory documentation to regulatory agencies or to commercial partners/distributors.
  • Ensure timely completion of license renewals, updates, and registrations.
  • Maintain accurate regulatory files/database and chronologies. Develop and implement a system for tracking changes in documents submitted to agencies or distributors.
  • Conduct reviews of labeling and labels to ensure compliance with regulatory requirements.
  • Evaluate changes to existing products and SOPs to determine the requirements for regulatory submissions.
  • Provide regulatory reviews of customer complaints and define regulatory reportability; manage vigilance reporting communication within GEM territory specifically in Eastern Europe, Middle East & Africa (EEMEA).
  • Maintain up-to-date knowledge of applicable regional regulation, guidance, and standards applicable to company products.
Quality Assurance
  • Ensure compliance with distributor requirements within GEM territory specifically in EEMEA by establishing and maintaining Distributor Quality Agreements.
  • 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.
Requirements
  1. Bachelor's degree or professional qualification, preferably in Life Science, Pharmacy, Biotechnology or any related technical field.
  2. 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. Able to work independently with minimal supervision.