Medical Device Registration and Approval Professional

7 days ago


Singapore Recruit Express Full time
Overview

We are looking for a Medical Device Registration and Approval Professional 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 Tasks: 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 Report Applications: Prepare clinical trial and evaluation report applications according to government regulations, hospital ethics committee needs, and company requirements for submission.
  • Local Language Labels 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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