MDR/Vigilance Specialist - Mounds View, MN
About The Position
In this exciting role as an 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 requirements. In conjunction with US and OUS regulatory reporting criteria, the MDR/Vigilance Specialist compiles regulatory reports for submission to the regulatory agencies, including the FDA. As part of complaint closure activities, this individual monitors complaint handling to ensure timely review of product feedback, product analysis, product investigations, and any related follow-up actions required for 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. This role has no travel requirements.
Requirements
- Requires a Bachelors degree in Health Care, Health Sciences, or Bio-Medical Engineering and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Nice To Haves
- Licensed Registered Nurse with clinical experience in the cardiovascular space
- Demonstrated technical writing experience, including the creation of clear and accurate documentation.
- Strong verbal communication skills and attention to detail
- 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.
Responsibilities
- Apply policies and procedures to comply with FDA and OUS regulations.
- Monitor the company's drug or medical devices surveillance program including the intake, evaluation, processing, and follow-up on adverse 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) and Vigilance Reports (VR) 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 with cross-functional partners internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
- Other duties as assigned.
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
Principal
