Regulatory Affairs Associate

8 hours ago

tamil nadu, India Aurolab Full time

Job Summary:A Regulatory Affairs Associate in the medical device industry supports the development,registration, and compliance of medical devices throughout their lifecycle. This entry-to-mid-level role ensures products meet regulatory standards set by bodies such as the FDA (U.S.),EU MDR (Europe), and other international authorities. The associate works closely withcross-functional teams (e.g., R&D, Quality Assurance, Clinical, and Marketing) to preparesubmissions, maintain documentation, and monitor regulatory changes, contributing to safeand timely market access for medical devices.Key Responsibilities:- Assist in preparing, reviewing, and submitting regulatory documents, TechnicalFiles/Dossiers for CE marking, and international registrations (e.g., for Canada, Australia, oremerging markets including 510(k) premarket notifications, Premarket Approval (PMA)applications.- Support regulatory assessments for OBL’s product changes, labeling updates, and post-market activities, such as Medical Device Reporting (MDR), vigilance reporting, and fieldactions/recalls.- Maintain and update regulatory databases, tracking submissions, approvals, and renewalson OBL products.- Monitor and interpret evolving regulations (e.g., FDA guidance, EU MDR, ISO 13485, ISO14971 for risk management) and communicate impacts to OBLs.- Support post-market surveillance, including adverse event reporting and compliance withUnique Device Identification (UDI) requirements of OBL products.Qualifications and Requirements:-Education: Bachelor’s degree in pharmacy.- Experience: 1–3 years in regulatory affairs, preferably in medical devices (Class I–III),pharmaceuticals, or a related regulated industry.Knowledge:- Familiarity with U.S. FDA regulations (21 CFR Parts 803, 820, 814), EU Medical DeviceRegulation (MDR 2017/745), MDSAP, and international standards (e.g., ISO 13485, ISO14971).- Understanding of medical device lifecycle, including design controls, clinical datarequirements etc….Skills:- Strong attention to detail and organizational abilities for managing complexdocumentation.- Excellent written and verbal communication for preparing submissions and interacting withagencies.- Analytical mindset to evaluate regulatory risks and changes.- Ability to work in a fast-paced, team-oriented environment.

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