Regulatory Affairs Job at Medtronic
Looking for a rewarding Regulatory Affairs Job with a global healthcare technology leader? Medtronic Careers is hiring a Regulatory Affairs Specialist in Hyderabad for professionals passionate about medical device regulations, global product registrations, and regulatory compliance. If you have experience with regulatory submissions, FDA and EU regulations, and cross-functional collaboration, this opportunity offers an excellent platform to build your career in Medical Device Jobs in India.
About the Company:
Medtronic is one of the world’s largest healthcare technology companies, dedicated to alleviating pain, restoring health, and extending life. Operating in more than 150 countries, Medtronic develops innovative medical discoveries that improve the lives of over 72 million patients annually. With a strong focus on innovation, quality, and patient care, the company offers professionals meaningful career opportunities, continuous learning, and the chance to contribute to life-changing healthcare solutions worldwide.
Job Details:
- Position: Regulatory Affairs Specialist
- Job Requisition ID: R69340
- Location: Nanakramguda, Hyderabad, India
- Work Arrangement: Flexible Work Arrangement
- Employment Type: Full-Time
Job Description:
Medtronic is seeking an experienced Regulatory Affairs Specialist to support global regulatory activities for medical device development and commercialisation. The role involves preparing regulatory submissions, developing regulatory strategies, collaborating with global teams, ensuring compliance with international regulations, and supporting product approvals across multiple markets. This position offers an opportunity to work in a dynamic environment focused on advancing innovative healthcare technologies.
Key Responsibilities:
- Prepare, review, and submit regulatory documents for global product registrations.
- Support premarket submissions and marketing authorizations.
- Develop regulatory strategies for new and modified medical devices.
- Review pre-clinical and clinical protocols and associated reports.
- Monitor changes in regulatory requirements and assess their business impact.
- Communicate with regulatory authorities and maintain regulatory correspondence.
- Prepare documentation for product modifications and change controls.
- Compile regulatory materials for license renewals and annual registrations.
- Participate in regulatory inspections and notified body audits.
- Author and update regulatory procedures and compliance documentation.
- Review promotional materials and labeling for regulatory compliance.
- Maintain regulatory files, reporting systems, and documentation.
Educational Qualification for this Regulatory Affairs Job:
Candidates should possess:
- Bachelor’s Degree in Medical Sciences
- Other Healthcare-related disciplines
Experience Required:
- 4–7 years of experience in Regulatory Affairs.
- Experience in the medical device and/or pharmaceutical industry.
- Knowledge of India, US FDA, and EU regulatory requirements.
- Experience supporting global regulatory submissions and approvals.
- Cross-functional collaboration experience is preferred.
Skills Required for this Regulatory Affairs Job:
- Strong understanding of medical device regulations.
- Knowledge of US FDA, EU MDR, and international regulatory requirements.
- Excellent technical writing and documentation skills.
- Regulatory submission preparation expertise.
- Strong organisational and project management skills.
- Excellent verbal and written English communication.
- Attention to detail and analytical thinking.
- Ability to manage multiple priorities under deadlines.
- Strong interpersonal and stakeholder management skills.
- Team-oriented mindset with a continuous learning attitude.
Preferred Skills
- Global Regulatory Affairs experience.
- Experience working with cross-functional international teams.
- Regulatory problem-solving and risk assessment.
- Project management capabilities.
- RAPS Regulatory Affairs Certification (RAC) is an advantage.
