Regulatory Affairs Specialist in Medical Devices
3 days ago
As a Regulatory Affairs Specialist in Medical Devices, you will play a critical role in ensuring the company's products meet regulatory requirements. You will work closely with cross-functional teams to prepare and complete product registration tasks, including new product registration, registration amendments, and renewal registrations.
Responsibilities:
• Prepare and submit product tests/samples to regulatory agencies for review and approval.
• 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 immediately.
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