Regulatory Affairs Specialist Medtronic – Apply Now!
Join Medtronic, a global leader in medical technology, as a Regulatory Affairs Specialist II in Nanakramguda, Hyderabad, India. Drive global regulatory strategies and ensure compliance for innovative medical devices that transform healthcare access worldwide. Be a key part of purpose-driven change in the life sciences industry.
- Job Position: Regulatory Affairs Specialist II
- Remote type: Hybrid
- Locations: Nanakramguda, Hyderabad, India
- Job requisition ID: R17738
About Medtronic
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
- Supporting Design and Development Control activities with regulatory requirements
- Prepare, review, file, and support premarket documents for global registrations
- Collaborate with business unit and international regulatory affairs personnel
- Review pre-clinical and clinical protocols
- Develop Regulatory Strategies for new or modified products
- Monitor changes in the regulatory environment
- Communicate with regulatory agencies
- Prepare internal documents for modifications to devices
- Participate in health agency inspections and notified body audits
- Review regulatory procedures and update as necessary
- Review promotional material, advertising, and labeling
- Ensure compliance to regulations specific to clearance and approvals
Required Knowledge and Experience
- Bachelor degree in Medical, Life Science or other healthcare related majors
- 4-7 years experiences for RA role in medical device and or pharmaceutical industry
- Good understanding for regulations and policies issued by India, US FDA and EU
- Excellent written, organizational, and communication skills
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package.
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