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Regulatory Affairs Specialist

2 weeks ago

Penang, Malaysia Ambu AS Full time
Job Description

Ambu Global Hub is currently seeking a highly skilled Regulatory Affairs Professional to join our Global Emerging Market (GEM) team based in Penang, Malaysia.

This role is responsible for managing Regulatory Affairs & Quality Assurance functions, ensuring compliance with regional regulations and standards.

Main Responsibilities
  1. Regulatory Affairs
  • Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners/distributors.
  • Timely compile materials for license renewals, updates, and registrations.
  • Maintain regulatory files/database and chronologies in good order. Establish and maintain a system for tracking changes in documents submitted to agencies or distributors.
  • Review labeling and labels for compliance with regulatory requirements.
  • Review changes to existing products and SOPs to define the requirements for regulatory submissions.
  • 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).
  • Maintain current knowledge of applicable regional regulation, guidance, and standards applicable to company products.
Quality Assurance
  • Responsible for specific distributor requirements within GEM territory specifically in EEMEA including ensuring establishment and maintenance of 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. 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.