Associate MDR/Vigilance Specialist
About The Position
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.
Requirements
- Bachelor's degree with 0 years of experience required.
Nice To Haves
- 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 activities.
- Experience preparing or maintaining documentation related to complaint handling, investigations, MDRs, or regulatory submissions.
- Experience with Medtronic Neurovascular products
- 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
- 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.
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)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
