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Job Title: Senior Manager – Regulatory Affairs Department: Regulatory Affairs Location: Gurugram, India Reporting to: Head – Quality & Regulatory Affairs Company: SS Innovations Pvt. Ltd. Job Summary: SS Innovations Pvt. Ltd., a pioneering medical device company focused on innovative surgical robotics, is seeking an experienced and highly motivated Senior Manager – Regulatory Affairs . The ideal candidate will have strong expertise in global regulatory frameworks including US FDA , EU MDR/CE , and other major international standards (e.g., TGA, Health Canada, CDSCO). This role involves overseeing regulatory strategies, managing submissions, ensuring compliance, and facilitating approvals for new and existing medical devices. Key Responsibilities: Regulatory Strategy & Compliance: Develop and implement regulatory strategies for global markets (US, EU, India, etc.) to ensure timely product approvals and market entry. Monitor regulatory changes and communicate impact to internal stakeholders. Product Submissions & Approvals: Lead the preparation, submission, and management of regulatory dossiers including 510(k) , PMA , Technical Documentation for CE marking , and Indian CDSCO approvals . Coordinate with notified bodies, regulatory agencies, and consultants as needed. Quality System Support: Support Quality Management System (QMS) compliance as per ISO 13485 , 21 CFR Part 820 , and MDSAP requirements. Participate in internal and external audits, including FDA inspections and CE audits. Cross-Functional Collaboration: Work closely with R&D, Clinical, Manufacturing, and Marketing teams during product development to ensure regulatory requirements are integrated early. Provide regulatory guidance on labeling, promotional materials, and product changes. Regulatory Intelligence & Risk Management: Maintain a robust understanding of international regulatory landscapes. Identify regulatory risks and develop mitigation strategies. Team Leadership & Development: Lead and mentor the regulatory affairs team. Develop team capabilities in line with evolving regulatory requirements. Desired Profile: Education: Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or related discipline. Experience: Minimum 10–12 years of regulatory affairs experience in the medical device industry , with proven exposure to US FDA , CE (EU MDR) , and global regulatory markets . Certifications: RAC (Regulatory Affairs Certification) preferred. Skills: In-depth knowledge of international regulatory requirements and submission processes. Strong project management and leadership abilities. Excellent communication and interpersonal skills. Ability to work in a dynamic, fast-paced environment with cross-functional teams. Why Join SS Innovations? Work with cutting-edge technology in surgical robotics. Be part of a growing global medtech innovator. Collaborate with a passionate and multidisciplinary team. Opportunities for global exposure and career advancement. Show more Show less
