Senior Regulatory Affairs Specialist

Job description

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the LifeThe Regulatory Affairs function is responsible for enabling patient access to Medtronic therapies by ensuring products meet applicable regulatory requirements throughout their lifecycle. This role supports Medtronic's medical device portfolio in India, partnering with global and local stakeholders to manage regulatory submissions, product registrations, license maintenance, post-approval changes, and compliance activities across multiple therapy areas. The Senior Regulatory Affairs Specialist serves as the regulatory lead for assigned product portfolios, supporting market access, product lifecycle management, and regulatory compliance across India. The role works closely with commercial, operational, clinical, and global regulatory teams to execute regulatory strategies, maintain licenses, and deliver timely approvals that support business objectives and uninterrupted product availability. Primary Responsibilities Manage product registrations, import licenses, renewals, and post-approval change submissions for medical devices in India. Develop and execute regulatory strategies supporting new product introductions and lifecycle management activities. Interface with regulatory authorities including Central Drugs Standard Control Organization (CDSCO), State Food and Drug Administration (FDA) authorities, Bureau of Indian Standards (BIS), Department of Telecommunications (DoT), and Customs authorities. Prepare, review, and submit regulatory documentation to support product approvals, license maintenance, and compliance requirements. Partner with Sales, Marketing, Supply Chain, Clinical Affairs, and Global Regulatory teams to support business priorities and market access objectives. Monitor submission timelines, approval status, and regulatory milestones to ensure delivery against commitments and key performance indicators. Provide regulatory guidance on compliance, product changes, and regulatory requirements impacting business operations. Maintain accurate regulatory records and support responses to regulatory queries, reviews, and inspections. Required Qualifications Bachelor's degree OR Master's degree in Pharmacy, Biomedical Engineering, with relevant Regulatory Affairs experience in Medical Devices or Pharmaceuticals. Experience with product registrations, licensing, post-approval changes, and regulatory submissions. Knowledge of Indian Medical Device Rules and regulatory requirements administered by CDSCO and related regulatory authorities. Experience interacting with regulatory agencies and managing regulatory documentation throughout the product lifecycle. Ability to manage multiple regulatory projects and competing priorities. Preferred Profile M.Pharm with Regulatory Affairs experience in the Medical Device industry. Experience within multinational Medical Device or Pharmaceutical organizations. Experience supporting multiple therapy areas and diverse product portfolios. Experience developing regulatory strategies and resolving complex regulatory challenges. Exposure to clinical trial regulatory activities and collaboration with global regulatory teams. 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. ‌ ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. Benefits & CompensationMedtronic 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).