Associate MDR​/Vigilance Specialist

We anticipate the application window for this opening will close on - 17 Sep 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.

The Associate MDR Vigilance Specialist is responsible for supporting post-market surveillance and complaint handling activities to ensure continued compliance with global medical device regulations. This role reviews and evaluates customer complaints, adverse events, and product performance data to determine reportability requirements, supports regulatory submissions, and collaborates with cross-functional partners to ensure timely and accurate documentation of product-related events.

Based in Mounds View, MN, this position plays an important role in Medtronic's Mission to alleviate pain, restore health, and extend life by supporting post-market surveillance activities and driving continuous improvement across the product lifecycle. The Associate MDR Vigilance Specialist contributes to protecting patients and customers through accurate documentation, trend monitoring, and adherence to regulatory and internal quality requirements.

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 5 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.

• Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
• Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
• Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

• Bachelor's degree with 0 years of experience required.

• 1+ year of experience supporting medical device complaint handling, vigilance, post-market surveillance, or MDR activities.
• Experience reviewing and documenting customer complaints, adverse events, or product performance events in a regulated environment.
• Exposure to FDA Medical Device Reporting (MDR) requirements and/or global vigilance regulations.
• Experience working within a quality management system compliant with 21 CFR Part 820, ISO 13485, or similar regulatory standards.
• Experience using complaint handling, case management, or quality system databases.
• Bachelor's degree in Engineering, Life Sciences, Biology, Chemistry, Healthcare, or a related technical discipline.
• Experience partnering with Quality, Regulatory Affairs, Manufacturing, Engineering, or Medical Safety functions to support investigations and documentation…