Regulatory Affair Professional

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 medical device industry with experience in regulatory affairs, this position would be suitable for you.

Key Responsibilities

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 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.
• Other duties as assigned.
  
  

Quality Assurance

• Responsible for specific distributor requirements within GEM territory specifically in EEMEA including ensuring establishment and maintenance of Distributor Quality Agreements.
• MAH/ supplier management per Corporate QA procedures.
  
  

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

Skills

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

• A minimum education in Bachelor's degree or professional qualification, preferably with major in Life Science, Pharmacy, Biotechnology or any related technical field.
• An established candidate with 5-6 years’ experience in Regulatory Affairs/ Medical Device industry.
• Quality assurance experience in medical industry would be an advantage.
• Can work independently with minimum supervision.
  
  

Ambu – a visionary and international workplace where your efforts matter

Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.



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.