MDR/Vigilance Specialist

Welcome to Medtronic, a global leader in medical technology and solutions. We are currently seeking a highly motivated and detail-oriented MDR/Vigilance Specialist to join our dynamic team. As a MDR/Vigilance Specialist, you will have the opportunity to play a critical role in ensuring the safety and effectiveness of our medical devices for patients worldwide. We are looking for individuals who are passionate about improving healthcare and have a strong understanding of regulatory requirements. If you are a proactive problem-solver with excellent communication skills, we encourage you to apply for this exciting opportunity. Keep reading to learn more about the qualifications and responsibilities for this role.

1. Monitor and analyze post-market surveillance data to identify and report any adverse events or product malfunctions in compliance with regulatory requirements.
2. Conduct thorough investigations into reported adverse events, collaborating with cross-functional teams to determine root cause and implement appropriate corrective and preventive actions.
3. Maintain accurate and up-to-date records of all adverse event reports, ensuring timely submission to regulatory authorities.
4. Stay current with regulatory guidelines and requirements related to medical device vigilance and complaint handling.
5. Coordinate with internal and external stakeholders to facilitate timely and accurate reporting of adverse events, including communication with healthcare providers and patients.
6. Collaborate with Quality and R&D teams to assess and mitigate potential risks and safety concerns related to medical devices.
7. Participate in audits and inspections related to post-market surveillance and vigilance activities.
8. Develop and maintain standard operating procedures and work instructions for post-market surveillance and vigilance processes.
9. Communicate effectively with cross-functional teams and management to provide updates on post-market surveillance activities and escalate any urgent issues.
10. Identify areas for process improvement and implement solutions to enhance the efficiency and effectiveness of post-market surveillance and vigilance processes.
11. Act as a subject matter expert for regulatory requirements and best practices related to post-market surveillance and vigilance.
12. Mentor and train new team members on post-market surveillance and vigilance processes and procedures.
13. Collaborate with international regulatory teams to ensure compliance with global medical device regulations.
14. Assist in regulatory submissions and registrations related to post-market surveillance and vigilance.
15. Uphold Medtronic's commitment to patient safety and product quality through compliance with all applicable regulations and standards.

According to JobzMall, the average salary range for a MDR/Vigilance Specialist in Minneapolis, MN, USA is $55,000 - $90,000 per year. This range can vary depending on factors such as experience, education, and specific job duties.

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.