Associate MDR/Vigilance Specialist

Posted 4 Days Ago
Be an Early Applicant
Mounds View, MN, USA
In-Office
64K-96K Annually
Entry level
Healthtech
The Role
Supports medical device post-market surveillance, complaint handling, adverse event evaluation, MDR reporting, regulatory submissions, and safety data quality. Reviews clinical and complaint databases, determines reportability, maintains accurate documentation, monitors trends, and collaborates with Quality, Regulatory Affairs, Engineering, Manufacturing, and Medical Safety teams. The role is fully onsite in Mounds View, Minnesota and focuses on compliance with global medical device regulations and quality system requirements.
Summary Generated by Built In
We anticipate the application window for this opening will close on - 17 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.

A Day in the LifeThe 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.

         

         

Responsibilities may include the following and other duties may be assigned.

  • 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.

Required Qualifications

  • Bachelor's degree with 0 years of experience required.

Preferred Qualifications

  • 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.

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.

Recruitment Fraud Alert

We are aware of phishing scams targeting job seekers. Please keep the following in mind: 


Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. 


Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. 


If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. 


If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected]

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):$64,000.00 - $96,000.00


This 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.

Skills Required

  • Bachelor's degree
  • For bachelor's degrees earned outside the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) requirements
  • 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 requirements and/or global vigilance regulations
  • Experience with quality management systems compliant with 21 CFR Part 820, ISO 13485, or similar 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
  • Experience preparing or maintaining complaint handling, investigation, MDR, or regulatory submission documentation
  • Experience with Medtronic Neurovascular products

Medtronic Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Medtronic and has not been reviewed or approved by Medtronic.

  • Healthcare Strength Health coverage is considered comprehensive, with high-quality medical, dental, and vision options through major providers and added mental-health resources. These programs are frequently highlighted as a core strength of the package.
  • Parental & Family Support Parental and family benefits stand out, including up to 24 weeks paid leave for U.S. birthing parents, 12 weeks for other parents, and a global Family Care Leave at 100% pay. Family-building support (fertility, adoption/surrogacy reimbursements) and backup care further reinforce this strength.
  • Retirement Support A 401(k) with company match is described as competitive and reliable for long-term savings. Additional financial programs, such as tuition assistance and charitable-gift matching, complement retirement planning.

Medtronic Insights

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The Company
HQ: Dublin
80,303 Employees
Year Founded: 1949

What We Do

Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions. Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year. To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.

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