Regulatory Affairs Specialist - II

Welcome to Medtronic, a global leader in medical technology, services, and solutions. We are seeking a highly motivated and detail-oriented individual to join our team as a Regulatory Affairs Specialist - II. As a Regulatory Affairs Specialist, you will play a critical role in ensuring that our products meet regulatory requirements and are safe for use by patients around the world. This position requires a strong understanding of regulatory guidelines and the ability to work collaboratively with cross-functional teams. If you have a passion for making a positive impact in the healthcare industry and possess the necessary qualifications, we invite you to apply for this exciting opportunity.

1. Ensure compliance with all applicable regulatory requirements and guidelines for medical devices.
2. Develop and maintain a thorough understanding of global regulatory requirements and communicate updates to relevant teams.
3. Prepare and submit regulatory submissions for new products, product changes, and post-market activities.
4. Collaborate with cross-functional teams to gather necessary information and documentation for regulatory submissions.
5. Conduct reviews and assessments of product labeling, advertising, and promotional materials to ensure compliance with regulatory requirements.
6. Manage and maintain product registrations, licenses, and certifications.
7. Stay current on industry and regulatory trends and communicate potential impacts to the company.
8. Participate in internal and external audits and inspections related to regulatory compliance.
9. Develop and maintain relationships with regulatory agencies to facilitate communication and expedite approvals.
10. Support product development by providing regulatory guidance and advice.
11. Monitor and track changes in regulations and communicate potential impacts to relevant teams.
12. Ensure timely and accurate completion of all required regulatory documentation and submissions.
13. Maintain and update regulatory files and documentation in accordance with company policies and procedures.
14. Participate in cross-functional meetings to provide regulatory guidance and support.
15. Continuously strive to improve processes and procedures related to regulatory affairs.
16. Effectively communicate with internal and external stakeholders regarding regulatory updates and requirements.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist - II in Nanakramguda, Telangana 500032, India is between ₹ 6,00,000 - ₹ 9,00,000 per year. This salary range can vary depending on factors such as experience, education, and the specific industry the individual is working in.

Medtronic plc is the world's largest medical device company that generates the majority of its sales and profits from the US healthcare system and is headquartered on the island of Ireland.