Associate MDR​/Vigilance Specialist

We anticipate the application window for this opening will close on - 21 Aug 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier  this exciting role as an Associate MDR/Vigilance Specialist, you will have the responsibility and authority to document and evaluate product feedback and product analysis results for Medtronic products to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines.

In conjunction with US and OUS regulatory reporting criteria, the Associate MDR/Vigilance Specialist compiles regulatory agency reports for submission. As part of complaint closure activities this individual performs activities to monitor complaint activity to ensure timely review of product feedback, product analysis, product formal investigation, and any associated follow-up actions that pertain to complaint closure.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Responsibilities may include the following and other duties may be assigned.

Apply policies and procedures to comply with FDA and OUS regulations.

Monitor the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.

Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.

Ensure complete, accurate, and timely submission of Medical Device Reports (MDRs), Vigilance Reports (VR) Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.

Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.

Maintain awareness of new products, government regulations and requirements.

Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements

Other duties as assigned.

Must Have:

Minimum Requirements To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.

Bachelor’s Degree with 0 years of work experience

Nice to Have Degree in Health Care, Sciences, or Bio-Medical Engineering Demonstrated technical writing experience, including the creation of clear and accurate documentation.

Utilized the Global Complaint Handling (GCH) system to support product quality and compliance activities.

Applied medical device industry knowledge to ensure adherence to regulatory and quality standards.

Leveraged knowledge of cardiac anatomy, physiology, and related medical conditions to support clinical and product-related activities.

Maintained advanced computer proficiency, including Microsoft Office Suite, SAP, Siebel, Oracle Clinical, and other business systems.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

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