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Hiring companyMedtronic
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Senior Regulatory Affairs Specialist
Nanakramguda, Hyderabad, India Full-time
About the role
Regulatory Affairs team at Medtronic ensures global compliance for medical devices and pharmaceuticals. The Senior Regulatory Affairs Specialist develops regulatory strategies, prepares submission packages, and liaises with health authorities to support product registrations. Nanakramguda, Hyderabad, India, on-site.
What you’ll do
- Develop regulatory strategies for new or modified products
- Prepare, review, file and support premarket documents for global registrations
- Coordinate and compile submission packages for international regulatory filings
- Communicate with regulatory agencies and maintain documentation
- Monitor regulatory changes and advise internal teams
What you’ll bring
- Bachelor's degree in medical, mechanical, electrical, life science or related field
- 7+ years regulatory affairs experience in medical device or pharmaceutical industry
Skills
Regulatory strategySubmission preparationAgency communicationDocument managementChange control
Benefits
- Competitive salary
- Flexible benefits package
- Short-term incentive (Medtronic Incentive Plan)
Education
Bachelor's