Sr Regulatory Affairs Manager

Welcome to Medtronic, a global leader in medical technology that improves the lives of millions of people around the world. We are seeking a highly experienced Sr Regulatory Affairs Manager to join our dynamic team and help us navigate the complex and ever-evolving regulatory landscape. As the Sr Regulatory Affairs Manager, you will play a critical role in ensuring compliance with regulations and driving strategic regulatory initiatives for our innovative medical devices. We are looking for a motivated and detail-oriented individual with a strong background in regulatory affairs and exceptional leadership skills. If you are passionate about making a positive impact in the healthcare industry and thrive in a fast-paced environment, we encourage you to apply for this exciting opportunity.

1. Develop and implement regulatory strategies to ensure compliance with global medical device regulations and standards.
2. Monitor and interpret changes in regulations and communicate updates to relevant stakeholders.
3. Collaborate with cross-functional teams to drive regulatory initiatives and ensure timely market clearance/approval for new products.
4. Lead regulatory submissions, including premarket notifications, registrations, and product renewals.
5. Maintain up-to-date knowledge of industry trends, best practices, and regulatory requirements.
6. Prepare and maintain regulatory documentation, including product labeling and technical files.
7. Represent the company in interactions with regulatory agencies and participate in audits and inspections.
8. Provide regulatory guidance and support to product development teams to ensure compliance throughout the product lifecycle.
9. Ensure timely and accurate completion of regulatory filings and responses to inquiries from regulatory agencies.
10. Develop and maintain relationships with key stakeholders, including internal teams, regulatory agencies, and industry associations.
11. Train and mentor junior regulatory affairs team members.
12. Contribute to the development and improvement of regulatory processes and procedures.
13. Manage and track regulatory submissions and approvals.
14. Monitor and report on regulatory compliance metrics.
15. Stay informed about the competitive landscape and provide insights on potential regulatory implications.
16. Represent the company at industry conferences and events.
17. Ensure all regulatory activities are performed in accordance with company policies and procedures.
18. Provide strategic input for new product development and product launch plans.
19. Collaborate with Quality and Clinical teams to ensure compliance with regulatory requirements for post-market surveillance and adverse event reporting.
20. Participate in cross-functional projects and provide regulatory expertise and guidance.

According to JobzMall, the average salary range for a Sr Regulatory Affairs Manager in Lafayette, CO, USA is $116,000-$136,000. This may vary depending on the specific company, industry, and level of experience of the individual.

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.