Senior Regulatory Affairs Specialist

At Medtronic, we are dedicated to transforming the healthcare industry and improving the lives of patients around the world. As a Senior Regulatory Affairs Specialist, you will play a crucial role in ensuring our products meet all regulatory requirements and standards, allowing us to bring life-saving treatments to those who need them most. We are looking for a highly skilled and experienced individual with a strong understanding of regulatory processes and a passion for driving innovation. If you are seeking a challenging and rewarding opportunity to make a meaningful impact, we invite you to join our team at Medtronic.

1. Research and stay updated on all relevant regulations and standards in the healthcare industry.
2. Develop and maintain strong relationships with regulatory agencies to ensure timely and accurate approvals for our products.
3. Collaborate with cross-functional teams to ensure all products meet regulatory requirements throughout the development process.
4. Provide guidance and support to product development teams on regulatory requirements and processes.
5. Prepare and submit regulatory submissions, including but not limited to premarket notifications, 510(k) applications, and premarket approval applications.
6. Conduct regulatory reviews of product labeling, advertising, and promotional materials to ensure compliance.
7. Lead regulatory audits and inspections and implement corrective actions as needed.
8. Monitor and track changes in regulations and proactively communicate potential impacts to the organization.
9. Serve as a subject matter expert on regulatory affairs and provide guidance and training to other team members.
10. Maintain accurate and up-to-date records of all regulatory activities and submissions.
11. Participate in industry conferences and workshops to stay current on regulatory trends and best practices.
12. Continuously identify and implement process improvements to enhance regulatory efficiency and effectiveness.
13. Manage and maintain relationships with external consultants and vendors, as needed.
14. Act as a liaison between Medtronic and regulatory agencies, addressing any questions or concerns in a timely and professional manner.
15. Ensure compliance with all company policies, procedures, and regulations.

According to JobzMall, the average salary range for a Senior Regulatory Affairs Specialist is $90,000 to $130,000 per year. This range may vary based on factors such as location, industry, level of experience, and education.

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.