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Regulatory Affairs Specialist at Medtronic
About Medtronic:
Join a dynamic team collaborating with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing, and Operations. As a Regulatory Affairs Specialist, you will support the Global Operating Unit Regulatory Affairs function, ensuring compliance with Indian and other applicable regulations and policies. Your role involves providing regulatory support for research and development activities at the MEIC.
Position Name: Regulatory Affairs Specialist
Organization: Medtronic
Qualifications:
- B.Pharm, M.Pharm, Pharm.D, MSc, BSc in Lifesciences
Experience:
- 4-7 years
Location:
- Hyderabad
Salary:
- Not disclosed
Job Responsibilities:
- Documentation and Filing:
- Prepare, review, file, and support premarket documents for global registrations for assigned projects.
- Develop regulatory strategies for new or modified products.
- Collaboration:
- Work with business unit and international regulatory affairs personnel to support marketing authorizations.
- Represent Regulatory Affairs in product development projects from concept through commercialization.
- Review and Compliance:
- Review pre-clinical, clinical protocols, and associated reports for submissions.
- Ensure regulatory compliance of promotional material, advertising, and labeling.
- Regulatory Communication:
- Communicate with regulatory agencies and notify bodies on administrative and routine matters.
- Participate in health agency inspections and notified body audits as necessary.
- Internal Processes:
- Document and maintain communication with health authorities.
- Prepare internal documents for device modifications when appropriate.
- Review change control documents for regulatory impact.
- Assist in developing and maintaining regulatory files, records, and reporting systems.
Additional Responsibilities:
- Monitor regulatory environment changes and provide impact information.
- Author and review regulatory procedures and update as necessary.
- Ensure compliance with regulations for MEIC-developed product raw materials and prototypes.
