Regulatory Affairs Specialist - Cardiac Surgery

Welcome to Medtronic, a global leader in medical technology and services. We are currently seeking a highly motivated and experienced Regulatory Affairs Specialist to join our team in the Cardiac Surgery division. In this role, you will be responsible for ensuring compliance with all regulatory requirements for our innovative cardiac surgery products. We are looking for an individual with a strong attention to detail, excellent communication skills, and a deep understanding of the regulatory landscape in the medical device industry. If you are passionate about making a positive impact on patient outcomes and thrive in a fast-paced, collaborative environment, we encourage you to apply.

1. Ensure compliance with all regulatory requirements for Medtronic's cardiac surgery products.
2. Monitor and stay updated on changes in the regulatory landscape within the medical device industry.
3. Collaborate with cross-functional teams to ensure timely and accurate submission of regulatory documents.
4. Review and approve product labeling, marketing materials, and other documentation to ensure compliance with regulatory requirements.
5. Conduct thorough research and analysis of relevant regulations and guidelines to provide guidance and recommendations to the team.
6. Prepare and submit regulatory filings to obtain necessary approvals for new products and changes to existing products.
7. Maintain accurate and up-to-date regulatory files and records.
8. Respond to inquiries and requests from regulatory agencies in a timely and professional manner.
9. Provide regulatory guidance and support to product development teams throughout the product lifecycle.
10. Participate in internal and external audits to ensure compliance with regulatory requirements.
11. Communicate and collaborate with international regulatory agencies to obtain and maintain necessary approvals for global product distribution.
12. Continuously evaluate and improve processes related to regulatory affairs to ensure efficiency and compliance.
13. Participate in trainings and workshops to stay updated on regulatory requirements and guidelines.
14. Act as a subject matter expert on regulatory affairs for the cardiac surgery division.
15. Adhere to Medtronic's code of conduct and ethical standards in all activities.

According to JobzMall, the average salary range for a Regulatory Affairs Specialist - Cardiac Surgery in Mounds View, MN 55112, USA is $75,000 - $110,000 per year. This range can vary depending on factors such as experience, education, and the specific company or organization the specialist works for. Other factors such as bonuses, benefits, and location may also impact the salary range.

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.