Medtronic - Director - Quality Assurance & Regulatory Affairs

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. Youll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the Life.Role Summary. The QARA Director for India will be responsible for leading a team supporting Quality Assurance and Regulatory Affairs activities in India. This leadership role is responsible for developing and executing regulatory strategies and maintaining quality related activities and systems to ensure compliance with Indian and international medical device regulations (e.g. CDSCO, ISO 13485/Indian GMP, US FDA, EU MDR). The QA/RA Director will oversee product registrations, audits, quality assurance programs, and act as the primary liaison with regulatory bodies. The QA/RA Director serves as a member of the leadership team for India and plays a critical role in strategic decision-making, influencing business performance, and driving continuous improvement in quality and regulatory processes.Key Responsibilities.- Lead Quality Assurance and Regulatory Affairs (QA/RA) activities in India, ensuring compliance with global and regional requirements.- Develop and implement regulatory strategies for India to ensure timely submission and approval of product registrations with CDSCO and other authorities.- Navigate a complex matrix environment, collaborating with commercial, supply chain, legal, and global QA/RA teams.- Partner with cross functional teams to manage licensing, submissions, renewals, inspections, post-market surveillance, and regulatory intelligence.- Translate regulations, requirements, and corporate guidelines into effective business processes and procedures; stay abreast of evolving regulations and regulator expectations.- Lead the development and strengthening of relationships with regulators and relevant industry organizations.- Lead the development and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and the Indian regulatory requirements, including managing internal and external audits.- Develop and maintain a quality strategy and plan for India in alignment with enterprise-wide quality objectives and KPIs.- Assume the role of Management Representative for the QMS and oversee and manage QMS processes e.g. CAPA, FCA, complaint handling, supplier and distributor management etc.- Drive continuous improvement initiatives and leverage shared services support to drive efficiencies.- Provide leadership, coaching, and mentorship to the QA/RA team to build leadership capabilities and foster a culture of quality, compliance, and operational excellence.Qualifications & Experience.- Minimum of 10-12 years of progressive experience in Quality Assurance and Regulatory Affairs, preferably in the healthcare industry and ideally within the MedTech sector.- Strong understanding of the Indian Medical Device Rules (IMDR) under Drugs & Cosmetics Act 1940 and global regulatory frameworks.- Proven leadership in managing audits and regulatory submissions (ideally with CDSCO).- Strong collaboration and communication skills to influence effectively in a matrixed environment.- Proven strategic thinking balancing immediate compliance with long-term capability building.- Bachelors or Masters degree in Life Sciences, Engineering, or related field preferable.Physical Job Requirements. The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.Benefits & Compensation. Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).About Medtronic. We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here. (ref:iimjobs.com)