Compliance & Regulatory Consultant

Compliance & Regulatory Consultant
Location : Bangalore/Hyderabad
Relevant Exp : 3-6 Years
Mode of Work : Hybrid – 2-3 Days
Job Summary
Client is seeking a Compliance & Regulatory Consultant with hands-on experience in EU MDR (2017/745) and/or IVDR (2017/746) to support regulatory compliance, CE Marking activities, product registrations, technical documentation, and lifecycle management of Medical Device and IVD products.
Key Responsibilities
Prepare, review, and maintain Technical Documentation and regulatory submissions.Support CE Marking activities and coordinate with Notified Bodies.Perform regulatory impact assessments for product, manufacturing, labeling, and process changes.Manage product registrations, renewals, and compliance activities.Contribute to Post-Market Surveillance (PMS) and vigilance activities.Collaborate with Quality, R&D, Clinical, Manufacturing, and Product Management teams.Ensure compliance with EU MDR, IVDR, and applicable quality standards throughout the product lifecycle.
Required Qualifications
Bachelor�s or Master�s degree in Life Sciences, Biomedical Engineering, Biotechnology, Pharmacy, or related discipline.3-6 years of Regulatory Affairs experience within Medical Devices and/or IVDs.Strong knowledge of EU MDR, IVDR, and CE Marking requirements.Experience with technical documentation, regulatory submissions, and change impact assessments.Understanding of medical device lifecycle management, risk management, and post-market surveillance.Excellent communication, documentation, and stakeholder management skills.
Preferred Qualifications
Experience supporting Class II/III Medical Devices and/or IVD products.Exposure to global regulatory frameworks such as FDA and Health Canada.RAC certification and familiarity with ISO 13485 and ISO 14971.
Key Skills
EU MDR, EU IVDR, CE Marking, Regulatory Submissions, Technical Documentation, Product Registration, Change Control Assessment, Notified Body Coordination, Post-Market Surveillance, Vigilance, Risk Management, Medical Devices, IVD Regulations, Regulatory Compliance, Lifecycle Management.

Work arrangement
Hybrid