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.