Senior Manager Regulatory Affairs

Company Description TTK HEALTHCARE LIMITED is a modern and diversified conglomerate with products in FMCG, Animal Welfare, Ortho, and Food Industries. Over the last six decades, TTK Healthcare has contributed to the advancement of the healthcare system in India through innovative products like the TTK Chitra Heart Valve. The company's divisions cater to consumer products, animal welfare, and orthopaedic implants, all built on trust, transparency, and relationships. Key Responsibilities : Develop and implement regulatory strategies for product registrations in India (CDSCO) mandatory, and aware of international markets (e.g., US FDA, EU MDR, ASEAN, etc.). Liaise with regulatory bodies and consultants to ensure timely approvals. Prepare, review, and submit dossiers, technical files, and post-market documentation. Maintain compliance with applicable regulations and standards (ISO 13485, MDR, QSR, etc.). Support internal teams on regulatory requirements across the product lifecycle—from R&D to post-market surveillance. Represent regulatory affairs department for inspections from regulatory authorities and audits from Notified Bodies Monitor changes in regulations and guide teams on impact and actions. Qualifications Over 10 years of relevant Medical Device experience. Regulatory Compliance and Regulatory Requirements skills Regulatory Affairs and Regulatory Submissions proficiency, especially Indian CDSCO – MDR 2017 and knowledge in US FDA, EU MDR etc. Quality System knowledge Experience in the healthcare industry or related field Strong attention to detail and analytical skills Effective communication and interpersonal abilities Bachelor’s degree in pharmacy, Life Sciences, Engineering or related field Relevant certifications in regulatory affairs Requirements: Deep understanding of medical device regulations (Indian MDR 2017, EU MDR 2017/745, EU MDCG, US FDA,). Excellent communication, documentation, presentation, organizational, and team management skills. Ability to navigate complex regulatory landscapes. Location: Chennai Remuneration: Competitive and based on experience. Reporting: Functional reporting to the Head of Corporate RA/QA and administrative reporting to the Head of Operations Ortho Division. Show more Show less