Regulatory Affairs Specialist - Medical Devices

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
Strong command of

EU MDR 2017/745 and/or IVDR 2017/746,

including technical documentation requirements, clinical eval...