Regulatory Affairs Specialist for Medical Devices

3 days ago


Singapore Recruit Express Full time
Job Summary
Recruit Express seeks a skilled Regulatory Affairs Specialist for Medical Devices to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the compliance of our medical device products with regulatory agencies worldwide. This role requires strong expertise in regulatory affairs, including product registration, clinical trials, and labeling requirements.

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
- Strong understanding of regulatory affairs principles and practices
- Excellent communication and collaboration skills
- Ability to work in a fast-paced environment and adapt to changing priorities
- Strong attention to detail and organizational skills

What We Offer:
- Competitive salary and benefits package
- Opportunities for professional growth and development
- Collaborative and dynamic work environment
- Recognition and rewards for outstanding performance


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