Regulatory Affairs Associate
2 weeks ago
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 with cross-functional teams (e.g., R&D, Quality Assurance, Clinical, and Marketing) to prepare submissions, maintain documentation, and monitor regulatory changes, contributing to safe and timely market access for medical devices.Key Responsibilities:- Assist in preparing, reviewing, and submitting regulatory documents, Technical Files/Dossiers for CE marking, and international registrations (e.g., for Canada, Australia, or emerging 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 field actions/recalls. - Maintain and update regulatory databases, tracking submissions, approvals, and renewals on OBL products. - Monitor and interpret evolving regulations (e.g., FDA guidance, EU MDR, ISO 13485, ISO 14971 for risk management) and communicate impacts to OBLs. - Support post-market surveillance, including adverse event reporting and compliance with Unique 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 Device Regulation (MDR 2017/745), MDSAP, and international standards (e.g., ISO 13485, ISO 14971). - Understanding of medical device lifecycle, including design controls, clinical data requirements etc….Skills:- Strong attention to detail and organizational abilities for managing complex documentation. - Excellent written and verbal communication for preparing submissions and interacting with agencies. - Analytical mindset to evaluate regulatory risks and changes. - Ability to work in a fast-paced, team-oriented environment.
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Head of Regulatory Affairs
2 weeks ago
New Delhi, India Inventia Healthcare Limited Full timeInventia is into pharmaceutical development and manufacturing from last 40 yrs. We partner with pharma companies to research, develop, manufacture and distribute OSD. Our Manufacturing plant is in Ambernath which produces range of OSD including capsules, tablets, Granules and Pellets. We are there in 45 countries and have 10 plus facility approvals including...
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New Delhi, India Inventia Healthcare Limited Full timeInventia is into pharmaceutical development and manufacturing from last 40 yrs. We partner with pharma companies to research, develop, manufacture and distribute OSD. Our Manufacturing plant is in Ambernath which produces range of OSD including capsules, tablets, Granules and Pellets. We are there in 45 countries and have 10 plus facility approvals including...
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