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:
5–10 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 evaluation, and conformity assessment routes
Working knowledge of  FDA regulatory pathways: 510(k) substantial equivalence, PMA, De Novo,  and associated submission requirements
Experience working in or with a  regulatory consultancy, notified body, or CRO serving the medical device sector
Familiarity with  quality systems (ISO 13485)  and regulatory compliance processes.
Strong stakeholder communication and project management skills.