MDR/Vigilance Specialist (Medical Devices)

Location: Mounds View, Minnesota, United States; minimum four days per week onsite. No travel is required. Candidates must have unrestricted U.S. work authorization at hire and throughout employment; sponsorship is limited to Principal-level roles and above.

Salary: $82,400–$123,600 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global is a global healthcare technology company developing medical technologies focused on alleviating pain, restoring health, and extending life.

What you will do

• Document and evaluate product feedback and product analysis results to determine complaint status and regulatory reporting eligibility.
• Monitor medical device surveillance activities, including intake, evaluation, processing, and follow-up of adverse reports.
• Prepare and submit complete, accurate, and timely Medical Device Reports and Vigilance Reports to regulatory agencies, including the FDA.
• Monitor complaint handling, product investigations, and follow-up actions to support timely complaint closure.
• Collaborate with internal and external contacts to collect complaint information and meet regulatory reporting requirements.
• Maintain awareness of new products, regulations, and reporting requirements while supporting cross-functional programs and processes.

Requirements

• Bachelor’s degree in healthcare, health sciences, or biomedical engineering with at least 2 years of relevant experience, or an advanced degree with no experience.
• Unrestricted U.S. work authorization is required; this role does not offer sponsorship.
• Ability to apply FDA and international regulatory requirements to medical device surveillance and reporting.
• Strong technical writing, verbal communication, attention to detail, and documentation skills.
• Ability to work onsite at least four days per week in Mounds View, Minnesota.

Nice to have

• Registered Nurse license with clinical experience in the cardiovascular field.
• Experience with the Global Complaint Handling system and medical device quality or compliance activities.
• Knowledge of cardiac anatomy, physiology, and related medical conditions.
• Experience with Microsoft Office, SAP, Siebel, Oracle Clinical, and other business systems.

Culture & Benefits

• In-person collaboration and cross-functional professional development are emphasized.
• Health, dental, and vision insurance, plus health and flexible spending accounts for eligible regular employees.
• 401(k) plan with employer contribution and match, paid time off, paid holidays, and short-term disability benefits.
• Tuition assistance or reimbursement, life insurance, long-term disability leave, and employee assistance programs.
• Employee Stock Purchase Plan and incentive plans are available to regular employees.