Device Regulatory Compliance Expert
4 days ago
We are seeking a talented Device Regulatory Compliance Expert to join our team at Recruit Express. As a key member of our regulatory affairs department, you will be responsible for ensuring the compliance of our medical devices with regulatory agencies.
Main Responsibilities:
- Product Registration: Prepare and complete product registration tasks covering new product registration, registration amendment, and renewal registration.
- Collaboration with Lab Technicians: Collaborate with lab technicians to ensure product tests/samples meet safety and performance requirements of regulatory agencies.
- Clinical Trial and Evaluation Reports: Prepare clinical trial and evaluation report applications according to government regulations, hospital ethics committee needs, and company requirements for submission.
- Labeling and Instructions: Create local language labels and Instruction For Use in compliance with country regulations before passing them to Supply Chain.
- Regulatory Liaison: Liaise with regulatory agencies to facilitate and expedite review and approval of company products, registrations, submissions, reformulations, etc.
- Record Maintenance: Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements.
- Regulatory Liaison Throughout Product Lifecycle: Serve as regulatory liaison throughout product lifecycle.
- Regulatory Strategy and Operating Plans: Participate in regulatory strategy and operating plans.
- Product Recall Reporting: Handle product recall reporting to regulatory agencies for products exhibiting non-compliance.
- Marketing Advertisements: 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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