
MDR Vigilance Specialist II
Are you passionate about making a positive impact on people's lives? Do you thrive in a fast-paced and dynamic environment? If so, we have an exciting opportunity for you as a MDR Vigilance Specialist II at Medtronic.As a global leader in medical technology, Medtronic is dedicated to improving the health and well-being of patients around the world. As a MDR Vigilance Specialist II, you will play a critical role in ensuring the safety and effectiveness of our medical devices by managing post-market surveillance activities in compliance with regulatory requirements.We are seeking a highly organized and detail-oriented individual with a strong background in medical device regulations and vigilance reporting. The ideal candidate will have excellent communication skills and be able to work collaboratively with cross-functional teams to drive continuous improvement and mitigate potential risks.If you are passionate about making a difference and have the qualifications and drive to excel in this role, we invite you to apply and join our team at Medtronic.
- Manage post-market surveillance activities in compliance with regulatory requirements to ensure the safety and effectiveness of Medtronic's medical devices.
- Conduct thorough investigations and evaluations of reported adverse events and complaints related to Medtronic's medical devices.
- Collaborate with cross-functional teams to identify and implement corrective and preventive actions to mitigate potential risks.
- Ensure timely and accurate reporting of adverse events and complaints to regulatory authorities and internal stakeholders.
- Monitor and analyze trends in adverse events and complaints to identify potential safety issues and drive continuous improvement.
- Maintain a comprehensive understanding of medical device regulations and guidelines, including MDR and other global regulations, to ensure compliance in all vigilance activities.
- Act as a subject matter expert on medical device vigilance and provide guidance and support to internal teams.
- Communicate effectively with internal and external stakeholders, including regulatory authorities, to ensure timely and accurate reporting of adverse events and complaints.
- Contribute to the development and improvement of internal processes and procedures related to post-market surveillance.
- Stay up-to-date on industry developments and changes in regulations to proactively identify potential impact on Medtronic's medical devices and vigilance processes.
- Train and mentor junior team members on medical device vigilance and regulatory requirements.
- Maintain accurate and organized documentation of all vigilance activities and ensure compliance with internal and external audit requirements.
- Represent Medtronic in a professional and ethical manner, adhering to company values and code of conduct at all times.
- Continuously seek opportunities for personal and professional growth and development to excel in the role of MDR Vigilance Specialist II.
Bachelor's Degree In A Related Field Such As Healthcare, Nursing, Or Biomedical Engineering.
Minimum Of 3 Years Of Experience In Medical Device Vigilance, Adverse Event Reporting, Or Regulatory Compliance.
Strong Knowledge And Understanding Of Global Medical Device Regulations, Including Mdr, Fda, And Iso.
Experience With Medical Device Reporting (Mdr) Submissions And Adverse Event Investigations.
Excellent Analytical And Problem-Solving Skills, With The Ability To Prioritize And Manage Multiple Tasks And Deadlines.
Quality Assurance
Communication Skills
Data Analysis
Time Management
Incident Management
Root Cause Analysis
Medical Terminology
Risk assessment
Teamwork
Regulatory compliance
Adverse Event Reporting
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a MDR Vigilance Specialist II in Nanakramguda, Telangana 500032, India is between ₹8,00,000 to ₹12,00,000 per year. This may vary depending on the specific company, experience level, and skills of the individual.
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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.

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