
Medtronic, a global leader dedicated to pushing the limits of healthcare technology, therapies, and services to alleviate pain, restore health, and extend life, has announced an exciting career opportunity for a Regulatory Affairs Specialist based in Nanakramguda, Hyderabad.
Role Overview and Responsibilities
The Regulatory Affairs Specialist will support design and development control activities with regulatory requirements, directions, tactics, and strategies within a collaborative team environment. Key responsibilities include:
- Premarket & Global Submissions: Prepare, review, file, and support premarket documents for global registrations, and collaborate with business units to secure marketing authorizations.
- Protocol & Regulatory Strategy Reviews: Review pre-clinical and clinical protocols, develop regulatory strategies for new or modified products, and monitor regulatory environment changes.
- Compliance & Audits: Participate in health agency inspections and notified body audits, review promotional materials and labeling for compliance, and maintain comprehensive regulatory files and records.
Candidate Profile and Qualifications
- Education: Bachelor’s degree in Medical, Mechanical, Electrical, Life Sciences, or other healthcare-related majors.
- Experience: 4 to 7 years of regulatory affairs experience within the medical device and/or pharmaceutical industry (a mix is preferred).
- Core Competencies: Good understanding of regulations and policies issued by India, the US FDA, and the EU; excellent written, organizational, and communication skills; and a detail-oriented, flexible approach.
Application Details
- Company: Medtronic
- Position: Regulatory Affairs Specialist
- Location: Nanakramguda, Hyderabad
- Industry Type: Pharma / Healthcare / Clinical Research
- Application Deadline: 10th October 2026
