Contract Regulatory Affairs Specialist
3 weeks ago
- Monthly Salary: Up to $5000
- Location: Novena
- To start in May / Jun 2025
Key Responsibilities:
- Product Registration : Prepare and complete tasks for new product registration, registration amendments, and renewal registrations. Ensure product tests and samples meet safety and performance requirements of regulatory agencies in collaboration with lab technicians.
- Clinical Trials and Evaluation Reports : Prepare applications for clinical trials and evaluation reports according to government regulations, hospital ethics committee needs, and company requirements for submission.
- Labeling and Instructions : Create local language labels and Instructions For Use in compliance with country regulations before passing them to the Supply Chain.
- Regulatory Liaison: Liaise with regulatory agencies to facilitate and expedite the review and approval of company products, registrations, submissions, and reformulations.
- Record Maintenance : Maintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirements.
- Regulatory Strategy: Serve as a regulatory liaison throughout the product lifecycle and participate in regulatory strategy and operating plans.
- Product Recall Reporting : Handle product recall reporting to regulatory agencies for products exhibiting non-compliance.
- Marketing Compliance: Review marketing advertisements to ensure compliance with regulations and submit them to the FDA for approval.
Qualifications:
- Min. Bachelor's Degree in a related field or a scientific discipline (e.g., Biology, Microbiology, Chemistry).
- Minimum of 3 years of previous related experience.
- Medical device regulatory background
- Experience in preparing domestic and international product submissions is preferred.
If interested, please email your resume to alexgoh@recruitexpress.com.sg or telegram me @alexgohhl
Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)
Tell employers what skills you haveExecutive Management
FDA
Risk Assessment
Labels
Regulatory Affairs
Healthcare
Supply Chain
Regulatory Strategy
Microbiology
Chemistry
Clinical Trials
Biology
Compliance
Team Lead
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