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 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.