Regulatory Affairs Specialist for Medical Devices
6 days ago
At Recruit Express, we're seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the compliance of our medical devices with regulatory agencies.
Key Responsibilities:
- Prepare and complete product registration tasks covering new product registration, registration amendment, and renewal registration
- Collaborate with lab technicians to ensure product tests/samples meet safety and performance requirements of regulatory agencies
- Prepare clinical trial and evaluation report applications according to government regulations, hospital ethics committee needs, and company requirements for submission
- Create local language labels and Instruction For Use in compliance with country regulations before passing them to Supply Chain
- Liaise with regulatory agencies to facilitate and expedite review and approval of company products, registrations, submissions, reformulations, etc.
- Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements
- Serve as regulatory liaison throughout product lifecycle
- Participate in regulatory strategy and operating plans
- Handle product recall reporting to regulatory agencies for products exhibiting non-compliance
- Review marketing advertisements to ensure compliance with regulations and submit to FDA for approval
Requirements:
- Degree in Biomedical/Material Science or relevant discipline
- Minimum 3 years of experience in RA work, particularly in medical devices
- Able to start from an agreed date
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