Senior Regulatory Affairs Specialist

IND India Medtronic Private Limited; Gurugram District; On-site; INR 2,000,000 - 2,800,000; Full time

Job summary

Medtronic in India seeks a Senior Regulatory Affairs Specialist to lead regulatory activities for the medical device portfolio, ensuring registrations, license maintenance, and post-approval changes are executed across India.

You will partner with Sales, Operations, Clinical Affairs, and Global Regulatory teams to align regulatory strategies with market access objectives and ensure uninterrupted product availability.

Qualifications

• Bachelor's degree OR Master's degree in Pharmacy, Biomedical Engineering with 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.

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 CDSCO, FDA, BIS, 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 timely approvals.

Skills

Regulatory affairs

Education

Bachelor's or Master's in Pharmacy or Biomedical Engineering

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 Life

The 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. 6-10 years of 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.

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). 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. We change lives. Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. We build extraordinary solutions as one team. With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. This life-changing career is yours to engineer. By bringing your ambitious ideas, unique perspective and contributions, you will… Build a better future, amplifying your impact on the causes that matter to you and the world Grow a career reflective of your passion and abilities Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: Experiences that put people first. Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. Life-transforming technologies. No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. Better outcomes for our world. Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here.