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 Regulatory Affairs Specialist II to join our team. This role requires strong analytical skills, a deep understanding of regulatory requirements, and the ability to collaborate with cross-functional teams. As a Regulatory Affairs Specialist II, you will play a critical role in ensuring that our products meet all necessary regulatory standards and approvals. If you have a passion for making a difference in the lives of patients and are looking for a challenging and rewarding career, we encourage you to apply.

1. Conduct thorough research and analysis of global regulatory requirements for medical devices.
2. Collaborate with cross-functional teams including R&D, Quality, and Clinical to ensure regulatory compliance throughout the product development process.
3. Prepare and submit regulatory submissions to global regulatory authorities for new products, changes to existing products, and renewals.
4. Act as a liaison with regulatory agencies and respond to any queries or requests for information in a timely manner.
5. Review and approve labeling, marketing materials, and promotional activities to ensure compliance with regulatory requirements.
6. Develop and maintain regulatory strategies for new and existing products, including risk assessments and gap analyses.
7. Stay updated on changes and updates in regulations and communicate any potential impact to the company.
8. Participate in internal and external audits to ensure compliance with regulatory requirements.
9. Support post-market surveillance activities, including complaint handling and adverse event reporting.
10. Maintain accurate and up-to-date documentation of all regulatory activities and submissions.
11. Train and educate team members on regulatory requirements and processes.
12. Provide guidance and support to cross-functional teams to ensure timely and successful completion of projects.
13. Participate in continuous improvement initiatives to streamline regulatory processes and increase efficiency.
14. Adhere to ethical and legal standards in all regulatory activities.
15. Represent the company in a professional manner at conferences, seminars, and meetings with regulatory agencies.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist II in Nanakramguda, Telangana 500032, India is approximately $50,000 to $70,000 USD per year. This may vary depending on the specific company, level of experience, and other factors.

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.