Senior Regulatory Affairs Specialist - ET
Medtronic
Nanakramguda, Hyderabad, India (Hybrid)
Full-time
As a Senior Regulatory Affairs Specialist at Medtronic, you'll play a key role in ensuring global compliance by developing and implementing regulatory processes. You'll contribute to global registrations, audits, inspections, and strategic planning for new or modified medical devices, all while collaborating across international teams.
Serve as Process SME and provide coordination for data interpretation.
Stay updated on global regulatory procedures and changes.
Provide regulatory data and documents for tenders and submissions.
Prepare, review, and file global premarket documents.
Support marketing authorizations with international regulatory teams.
Compile and prepare submission materials and internal audit documentation.
Recommend changes to labeling, manufacturing, and clinical protocols for compliance.
Monitor and enhance tracking/control systems.
Communicate with regulatory agencies on administrative matters.
Develop regulatory strategies for new/modifications to products.
Maintain communication and documentation with health authorities.
Author/review regulatory procedures and conduct regulatory assessments.
Review change control documents to determine regulatory impact.
Bachelor’s degree in Medical, Mechanical, Electrical, Life Sciences, or other healthcare-related majors.
7+ years of Regulatory Affairs experience in medical device and/or pharmaceutical industry.
Capable of working independently on moderately complex projects.
Strong ability to communicate and collaborate internally across departments.
Proven ability to contribute to and complete project milestones.
Problem-solving skills with a focus on systems/process improvements.
Knowledge and experience in US and global regulatory affairs.
Experience collaborating with cross-functional teams.
Excellent verbal and written communication skills.
Strong project management experience with adherence to timelines.
Organized, detail-oriented, and efficient in dynamic settings.
Strong team player mindset with interpersonal and influencing skills.
RAPS Regulatory Affairs Certification (RAC) is a plus.
Responsibilities and qualifications listed are not exhaustive of all required duties and skills.
Competitive salary and flexible benefits package.
Access to a wide range of resources and career development opportunities.
Recognition and rewards aligned with employee contributions.
Supportive of work-life balance and career stage transitions.
Medtronic is a global healthcare technology leader with a mission to alleviate pain, restore health, and extend life. With 90,000+ employees worldwide, Medtronic fosters innovation and collaboration to tackle some of healthcare’s most pressing challenges. Employees are encouraged to explore, create, and solve, as part of a global team making meaningful change.
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