NTT DATA is looking for a skilled Compliance & Regulatory Consultant to join our team in Hyderabad, Telangana, and Bangalore. This role is ideal for professionals passionate about driving innovation within a dynamic and inclusive organization. Join us to shape the future of regulatory compliance for medical and IVD products.

Key responsibilities include preparing and maintaining technical documentation and regulatory submissions, supporting CE Marking initiatives, and coordinating with Notified Bodies. You will conduct regulatory impact assessments for various product changes, manage product registrations and renewals, and contribute to post-market surveillance and vigilance activities. Collaboration with Quality, R&D, Clinical, Manufacturing, and Product Management teams is essential for ensuring compliance throughout the product lifecycle.

We require candidates with a Bachelor's or Master's degree in Life Sciences, Biomedical Engineering, Biotechnology, Pharmacy, or a related field. A minimum of 3-6 years of experience in Regulatory Affairs within the Medical Device and/or IVD sectors is necessary. Strong knowledge of EU MDR, IVDR, and CE Marking requirements, along with experience in technical documentation and regulatory submissions, is crucial. Familiarity with medical device lifecycle management, risk management, and post-market surveillance is expected. Excellent communication and stakeholder management skills are vital for success in this role.