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 pathw...