Senior Regulatory Affairs Specialist
Medtronic INC · 🌍 Gurgaon, Haryana, India
Sponsorship verdict
No sponsorship evidence yet
No government record and no wording either way. Not a refusal — ask the recruiter.
- No government sponsor record hereNo government sponsor record covers this employer in this country.
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- Can’t check pay against the visa rulesWe don’t have visa salary rules for this country yet.
- Confirmed live todayWhen a source last listed this job as open.
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
Or apply yourself on the official page →
Why not apply?
No register record and no sponsorship wording in the posting. Worth asking the employer before investing significant time.
SponsorApply flags time-wasters so your applications go where they can land. These come from the posting's own wording — read the original listing to confirm. See better-fit alternatives →
Sponsor Radar — Medtronic INC
No government sponsor record covers this employer in this country.
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Medtronic INC →
About the role
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 performe