Associate MDR/Vigilance Specialist

Medtronic • Mounds View, MN

8d • $64,000 - $96,000 • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal