Associate MDR​/Vigilance Specialist

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.

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.

• 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.

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

• 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: 21
  
  CFR, Section 820, Quality System Regulation 21
  
  CFR Section 803, Medical Device Reporting ISO 13485, Quality Systems, Quality Management Systems 45
  
  CFR, 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  - 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.

The above statements are intended…