MDR Vigilance Specialist II

Welcome to Medtronic, a global leader in medical technology and solutions that improve the lives of millions of people around the world. We are currently seeking a highly skilled MDR Vigilance Specialist II to join our dynamic team. As a member of our team, you will play a critical role in ensuring compliance with the Medical Device Regulation and other relevant regulatory requirements. You will be responsible for conducting risk assessments, investigating complaints and adverse events, and implementing corrective and preventive actions to ensure patient safety. If you are passionate about making a difference in the healthcare industry and have a strong understanding of medical device regulations, we encourage you to apply for this exciting opportunity.

1. Conduct risk assessments to identify potential hazards and risks associated with medical devices.
2. Investigate complaints and adverse events related to Medtronic products and determine appropriate actions to ensure compliance with regulatory requirements.
3. Collaborate with cross-functional teams to develop and implement corrective and preventive actions to address identified issues.
4. Monitor and track all reported complaints and events to ensure timely and accurate reporting to regulatory authorities.
5. Keep up-to-date with relevant medical device regulations and standards and ensure Medtronic's compliance with them.
6. Act as a subject matter expert on MDR and other relevant regulatory requirements, providing guidance and support to internal teams.
7. Develop and maintain standard operating procedures and work instructions related to MDR vigilance activities.
8. Liaise with regulatory agencies and notified bodies as needed to address any compliance concerns.
9. Participate in internal and external audits related to MDR vigilance activities and ensure timely closure of any findings.
10. Continuously identify opportunities for process improvement and implement best practices to enhance the MDR vigilance process.
11. Communicate and collaborate effectively with internal stakeholders, including R&D, Quality, and Commercial teams.
12. Contribute to the development and delivery of training programs on MDR vigilance requirements and processes.
13. Maintain accurate and complete records of MDR vigilance activities and prepare reports for management as needed.
14. Act as a resource for colleagues and provide guidance and support on MDR vigilance activities.
15. Adhere to all company policies, procedures, and ethical standards to ensure compliance with applicable laws and regulations.

According to JobzMall, the average salary range for a MDR Vigilance Specialist II in Nanakramguda, Telangana 500032, India is approximately 4,50,000 INR to 6,00,000 INR per year. This may vary depending on the specific company, industry, and individual qualifications and experience.

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.