Regulatory Affairs Specialist - II
Medtronic
Nanakramguda, Hyderabad, India (Hybrid)
Full-time
As a Regulatory Affairs Specialist - II at Medtronic, you’ll support design and development control activities aligned with global regulatory requirements. This role involves working with cross-functional teams to ensure product compliance, prepare regulatory submissions, and maintain communication with health authorities.
Support regulatory requirements and strategy during product design and development.
Prepare, review, file, and support premarket regulatory documents for global submissions.
Collaborate with international RA personnel to support marketing authorizations.
Review pre-clinical and clinical protocols and reports for regulatory submissions.
Develop regulatory strategies for new or modified products.
Monitor regulatory environment changes and provide impact assessments.
Maintain oral and written communications with health authorities.
Prepare internal documentation for device modifications.
Participate in health agency inspections and notified body audits.
Author/review regulatory procedures and perform document assessments.
Maintain regulatory files and retrieval systems.
Ensure marketing materials and labels comply with regulatory requirements.
Ensure MEIC-developed product components comply with clearance/approval regulations.
Bachelor’s degree in Medical, Mechanical, Electrical, Life Sciences, or related healthcare field.
4–7 years of experience in Regulatory Affairs in the medical device or pharmaceutical industry.
Strong understanding of regulatory frameworks (India, US FDA, EU).
Excellent written, organizational, and communication skills.
Detail-oriented with multitasking, planning, and problem-solving abilities.
Proficient in English (spoken and written).
Team-oriented attitude and eagerness to learn.
Experience in global regulatory affairs (especially US).
Cross-functional team collaboration experience.
Strong communication and problem-solving skills.
Project management experience and ability to meet deadlines.
Comfortable in dynamic environments and working under pressure.
Highly organized and efficient.
Strong team player with professional demeanor and negotiation skills.
RAPS RAC Certification.
Proactive learner and adaptable to the evolving regulatory landscape.
Competitive salary and flexible benefits.
Career development programs and global growth opportunities.
Recognition and rewards for contributions.
Comprehensive support for every career and life stage.
Medtronic is a global leader in healthcare technology with over 90,000 employees worldwide, committed to alleviating pain, restoring health, and extending life. The company values innovation, diversity, and collaboration to solve humanity’s most challenging health problems.
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