MDR/Vigilance Specialist - Mounds View, MN

A Day in the Life

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.

Primary 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.

Required Qualifications:

• 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.

Preferred Qualifications:

• 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.

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 independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$82,400.00 - $123,600.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.