Regulatory Affairs Job at Medtronic
Looking for a rewarding Regulatory Affairs Job with a global healthcare innovator? Medtronic Careers has announced an exciting opportunity for professionals seeking Jobs in Hyderabad as a Regulatory Affairs Specialist. This role offers hands-on experience with global submissions, medical device compliance, regulatory strategy, and cross-functional collaboration. Candidates passionate about healthcare innovation, regulatory science, and international standards will find an excellent career pathway with one of the world’s leading medical technology companies.
About the Company:
Medtronic is a global leader in medical technology, healthcare solutions, and life sciences innovation. With a mission to improve lives and expand healthcare access, the company develops breakthrough technologies that address complex medical challenges worldwide. Medtronic fosters a culture of purpose, collaboration, and continuous learning, empowering employees to drive innovation and create meaningful impact for patients, healthcare providers, and communities worldwide.
Job Details:
- Job Position: Regulatory Affairs Specialist
- Job Requisition ID: R69340
- Location: Nanakramguda, Hyderabad, India
- Employment Type: Full-Time
- Work Arrangement: Flexible Work Arrangement
Job Description:
The latest Medtronic Careers opportunity invites applications for the Regulatory Affairs Specialist position based in Nanakramguda, Hyderabad. This Regulatory Affairs Job focuses on supporting global product registrations, developing regulatory strategies, maintaining compliance with international standards, and collaborating with cross-functional teams. The role provides exposure to India, the US FDA, and the EU regulatory frameworks, making it an excellent opportunity for professionals seeking long-term growth in medical device and healthcare regulation.
Key Responsibilities for Regulatory Affairs Job:
- Prepare, review, and file premarket documents for global registrations.
- Support marketing authorizations for assigned projects.
- Collaborate with international regulatory affairs teams.
- Review pre-clinical and clinical protocols and reports.
- Develop regulatory strategies for new and modified products.
- Monitor changes in global regulatory environments.
- Maintain communication with health authorities.
- Prepare internal documentation for device modifications.
- Support license renewals and annual registrations.
- Participate in health agency inspections and notified body audits.
- Author and update regulatory procedures.
- Assess regulatory impacts of change control documents.
- Maintain regulatory files, records, and reporting systems.
- Review promotional materials and labeling for compliance.
- Ensure regulatory approvals for raw materials and prototypes.
Educational Requirements:
- Bachelor’s degree in Medical Sciences
- RAPS Regulatory Affairs Certification (RAC)
- Additional global regulatory training is advantageous.
Experience Required:
- 4–7 years in Regulatory Affairs within the medical and/or pharmaceutical industries.
Skills Required for Regulatory Affairs Job:
- Strong understanding of India, US FDA, and EU regulations.
- Regulatory submission and documentation expertise.
- Medical device and pharmaceutical industry knowledge.
- Excellent written and verbal English communication skills.
- Organizational and project management abilities.
- Attention to detail and analytical thinking.
- Ability to manage multiple priorities under pressure.
- Cross-functional collaboration and teamwork skills.
- Problem-solving and decision-making capabilities.
- Negotiation and influencing skills.
- Strong interpersonal communication abilities.
- Adaptability and a continuous learning mindset.
