Location: Nanakramguda, Hyderabad
Industry: Pharma / Healthcare / Clinical Research
Functional Area: Regulatory Affairs
Experience Required: 4-7 years
End Date to Apply: 30th November 2024
About Medtronic:
At Medtronic, we are committed to pushing the boundaries of technology, therapies, and services to alleviate pain, restore health, and extend life. We strive to make tomorrow better than today by innovating solutions that address universal healthcare needs and improve patient outcomes.
Job Description:
As a Regulatory Affairs Specialist II, you will support design and development control activities, ensuring compliance with regulatory requirements and contributing to strategic direction. You will collaborate with cross-functional teams and provide regulatory input for product development from concept through commercialization.
Key Responsibilities:
- Prepare, review, and file premarket documents for global registrations of assigned projects.
- Collaborate with business units and international regulatory affairs teams to support marketing authorizations.
- Participate as a team member in product development projects, ensuring regulatory requirements are met throughout the product lifecycle.
- Review pre-clinical and clinical protocols and reports for submission.
- Develop regulatory strategies for new or modified products.
- Stay updated on changes in regulatory requirements and assess their impact on projects.
- Communicate with regulatory agencies regarding administrative and routine matters.
- Document and maintain communication with health authorities.
- Prepare internal documents for device modifications.
- Participate in health agency inspections and notified body audits when required.
- Author or review regulatory procedures and update as necessary.
- Review change control documents and assess their regulatory impact.
- Maintain regulatory files, records, and reporting systems.
- Review promotional materials, advertising, and labeling for regulatory compliance.
- Ensure compliance with regulations related to raw materials and prototypes of MEIC developed products.
Candidate Profile:
- Bachelor’s degree in Medical, Mechanical, Electrical, Life Sciences, or other healthcare-related fields.
- 4-7 years of experience in regulatory affairs in the medical device or pharmaceutical industry.
- Strong understanding of regulations and policies from India, US FDA, EU, and international regulatory requirements.
- Excellent written, organizational, and communication skills.
- Flexible, team-oriented attitude with attention to detail.
- Ability to handle multiple tasks, manage time effectively, and work under pressure.
- Strong command of the English language, including reading, writing, and speaking.
- Good learning attitude and a proactive approach.
Application Deadline: 30th November 2024