Job Description
Role: Medical Devices Regulatory Consultant
Key Responsibilities:
- Provide regulatory strategy and guidance for medical device products across global markets.
- Prepare and review regulatory submissions (e.G., 510(k), CE Mark, MDR/IVDR, and other regional filings).
- Ensure compliance with applicable regulatory requirements (FDA, EU MDR, ISO standards).
- Support product registration, regulatory documentation, and lifecycle management activities.
- Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing.
- Monitor regulatory changes and assess impact on ongoing projects.
Requirements:
- 5+ years of experience in medical device regulatory affairs.
- Bachelor's degree or higher in Biomedical Engineering, Life Sciences, Medical Technology, Pharmacy, or a related discipline