Associate MDR/Vigilance Specialist
Listed on 2026-09-12
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Healthcare
Healthcare Compliance, Medical Device Industry
Sep 2, 2026
$64,000 - $96,000/year
We anticipate the application window for this opening will close on - 5 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.
ADay in the Life
The Associate MDR/Vigilance Specialist supports the Post Market Quality organization by evaluating product feedback and complaint information for medical devices and determining regulatory reporting obligations in accordance with U.S. and international requirements. This function plays a key role in product surveillance, complaint management, and regulatory compliance by ensuring reportable events are accurately assessed, documented, and submitted to health authorities.
This position is based in Mounds View, Minnesota and follows an onsite work model with a minimum of four days per week in the office.
The Associate MDR/Vigilance Specialist is responsible for reviewing product feedback, complaint information, and product analysis findings to determine complaint and reportability status for medical devices. This role supports timely and compliant regulatory reporting activities, collaborates with cross-functional stakeholders, and contributes to complaint closure efforts through accurate documentation and follow-up.
Primary Responsibilities
Evaluate product feedback, complaint information, and product analysis results to determine complaint and regulatory reporting status.
Assess incoming events for Medical Device Reporting (MDR) and international vigilance reporting eligibility in accordance with applicable regulations and internal procedures.
Prepare, document, and submit complete and accurate regulatory agency reports within required reporting timelines.
Monitor complaint activities and support timely completion of complaint reviews, investigations, and closure requirements.
Collaborate with internal teams and external stakeholders to obtain and clarify information necessary for complaint processing and regulatory reporting.
Maintain complaint and reportability records in compliance with quality system requirements and regulatory standards.
Support ongoing surveillance activities by identifying and escalating potential reportable events and compliance concerns.
Remain current on regulatory requirements, reporting obligations, and product-related updates that may impact complaint handling activities.
Required Qualifications
Bachelor's degree with 0 years of work experience.
Ability to review, document, and manage detailed information in accordance with defined procedures and regulatory requirements.
Proficiency with Microsoft Office applications, including Word, Excel, and Outlook.
Ability to communicate effectively with internal and external stakeholders regarding complaint and regulatory reporting activities.
Preferred Qualifications
1+ years of experience supporting Medical Device Reporting (MDR), vigilance reporting, or complaint handling activities within the medical device industry.
Experience supporting Neuroscience products or therapies.
Degree in Healthcare, Life Sciences, or Biomedical Engineering.
Knowledge of medical device regulations, complaint handling processes, and post-market surveillance requirements.
Experience using systems such as SAP, Siebel, Oracle Clinical, or other quality and regulatory databases.
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.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles:
While performing the duties of this job, the employee is regularly required to be…
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