Regulatory Affairs Specialist-II
Medtronic
Nanakramguda, Hyderabad, India (Hybrid)
Full-time
As a Regulatory Affairs Specialist-II at Medtronic, you'll support the design and development of medical devices by ensuring compliance with global regulatory requirements. This role combines strategic planning with execution in a collaborative environment, and offers numerous opportunities for professional growth, skill development, and global impact.
Prepare, review, and file premarket documents for global registrations.
Collaborate with business units and international regulatory teams for marketing authorizations.
Review pre-clinical and clinical protocols and reports for submissions.
Develop regulatory strategies for new or modified products.
Monitor and assess regulatory changes and their impact.
Communicate with global health authorities.
Prepare internal documentation related to product modifications.
Support audits and inspections by health agencies.
Author/review regulatory procedures and update as needed.
Evaluate regulatory impact of change control documents.
Maintain regulatory records and systems.
Review promotional materials for regulatory compliance.
Ensure compliance of materials and prototypes to regulatory standards.
Bachelor’s degree in Medical, Mechanical, Electrical, Life Sciences, or other healthcare-related disciplines.
4–7 years of experience in Regulatory Affairs in the medical device or pharmaceutical industry.
Strong understanding of India, US FDA, and EU regulations.
Excellent communication, organization, and writing skills.
High attention to detail and ability to manage multiple tasks.
Strong English language proficiency (reading, writing, speaking).
A proactive learner with a team-oriented attitude.
Global regulatory affairs knowledge and experience.
Experience with cross-functional teams.
Problem-solving and project management experience.
Ability to manage projects to completion independently.
Strong interpersonal, influencing, and negotiation skills.
Familiarity with RAPS Regulatory Affairs Certification (RAC).
Experience in fast-paced, dynamic work environments.
This description outlines general responsibilities but is not exhaustive of all duties and skills required for the role.
Competitive salary and flexible benefits package.
Career growth and development programs.
A culture that values employee contributions and supports work-life balance.
Medtronic is a global leader in healthcare technology with over 90,000 employees worldwide. Their mission is to alleviate pain, restore health, and extend life. Medtronic fosters a culture of innovation, inclusion, and collaboration, empowering employees to engineer solutions that impact lives globally.
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