Associate MDR/Vigilance Specialist

Medtronic; Mounds View (MN); On-site; USD 64,000 - 96,000; Full time

Benefits offered by this job

Health

Dental and vision insurance

Health Savings Account

Healthcare Flexible Spending Account

Job summary

Medtronic is seeking an Associate MDR/Vigilance Specialist to manage the intake, documentation, and investigation of complaints for Endoscopy products in compliance with regulations and internal procedures. The role emphasizes in-person collaboration and a 5-day onsite workweek to support cross-functional growth.

The candidate will determine MDR eligibility, coordinate with reporters and healthcare professionals, and ensure timely regulatory submissions while upholding the Medtronic mission to

Qualifications

• Bachelor's degree required with 0 years’ experience in healthcare or medical device/pharmaceutical safety or clinical data evaluation.
• Strong analytical and problem-solving abilities; attention to detail.
• Excellent written and verbal communication; ability to work independently or in teams.

Responsibilities

• Receive and assess product comments to determine need for a complaint handling record.
• Document required information in Global Complaint Handling (GCH).
• Assess complaint file for missing information and initiate data gathering.
• Contact reporters, health care providers, patients, and field personnel as needed.
• Communicate professionally with outside parties to uphold Medtronic's brand and mission.
• Evaluate events to determine MDR and Vigilance reporting eligibility.
• Initiate and complete regulatory reports for FDA and other bodies.

Skills

Attention to detail

Analytical skills

Communication skills

Independence / team work

Education

Bachelor's degree in healthcare, biology, or related field

Degree in Health Care, Sciences, or Bio-Medical Engineering

Tools

Microsoft Office

SAP

Siebel

Oracle Clinical

Job description

We anticipate the application window for this opening will close on - 16 Oct 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 Life

Associate MDR/Vigilance Specialists are responsible for the intake, documentation, Medical Device Reporting, and investigation of complaints for Endoscopy products in accordance with applicable internal procedures (work instructions) and external requirements (regulations or guidance from all regulatory bodies). 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 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.

Primary Responsibilities

• Receive and assess product comments to determine need for complaint handling record.
• Document required information in Global Complaint Handling (GCH).
• Assess complaint file for missing required information.
• If information is missing, initiate attempts to gather information.
• Steps may include contacting: Medtronic Field Personnel Health Care Providers Patients or other initial reporters
• Communicate with outside parties in a professional and customer-focused manner that is in following with our Mission and enhances the Medtronic brand.
• Evaluate incoming product events to determine MDR and Vigilance reporting eligibility.
• Initiate and complete regulatory reports for timely submission to FDA and other regulatory bodies.
• Determine if investigation is necessary.
• If investigation is necessary, determine:
• Potential cause and contributing factors to the alleged event.
• Device relationship.
• If formal device investigation is necessary.
• Summarize the results of any investigation.
• Escalate complex issues to management.
• Execute other projects as assigned.

Required Qualifications

• Bachelors degree with 0 years’ experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation.

Preferred Qualifications

• High level of computer proficiency (e.g. Microsoft Office, SAP, Siebel, Oracle Clinical, etc.)
• 0-2 years’ experience in healthcare or medical device/pharmaceutical industry in safety or clinical data evaluation
• Degree in Health Care, Sciences, or Bio-Medical Engineering
• Strong attention to detail
• Knowledge of basic anatomy, physiology, and medical terminology
• Knowledge of: 21CFR, Section 820, Quality System Regulation 21CFR Section 803, Medical Device Reporting ISO 13485, Quality Systems, Quality Management Systems 45CFR, Parts 160 and 164, Patient Privacy Rule- HIPPA Regulations AIMD Directive: 90/385/EEC IVD Directive: 98/97/EC MDD Directive (Council Directive 93/42/EEC for Medical Devices) PC 1998-783 - Canadian Medical Device Regulation (CMDR)
• Complaint handling experience or customer service/technical support experience (0-2 years)
• Strong analytical skills (problem solving, critical thinking)
• Excellent communication skills (oral and written), with strong organizational and analytical skills
• Ability to work independently or in a team setting
• 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.

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).

• Health
• Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account