Regulatory Affairs Specialist - Medical Devices

Role: Medical Devices Regulatory ConsultantKey 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 disciplineStrong command of EU MDR 2017/745 and/or IVDR 2017/746, including technical documentation requirements, clinical evaluation, and conformity assessment routesWorking knowledge of FDA regulatory pathways: 510(k) substantial equivalence, PMA, De Novo, and associated submission requirementsExperience working in or with a regulatory consultancy, notified body, or CRO serving the medical device sectorFamiliarity with quality systems (ISO 13485) and regulatory compliance processes.Strong stakeholder communication and project management skills.

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