Associate MDR/Vigilance Specialist (Medical Devices)

Location: Mounds View, Minnesota, United States; onsite at least four days per week

Salary: $64,000–$96,000 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global is a global healthcare technology company developing medical technologies designed to alleviate pain, restore health, and extend life.

What you will do

• Review product feedback, complaints, and product analysis results to determine complaint status and regulatory reporting requirements.
• Assess adverse events and product performance issues against United States and international reporting criteria.
• Prepare Medical Device Reports and other submissions required by regulatory agencies.
• Monitor complaint records and support timely complaint review and closure.
• Maintain accurate, complete, and compliant documentation in complaint handling and post-market surveillance systems.
• Analyze complaint, investigation, and clinical data and collaborate with Quality, Regulatory Affairs, Engineering, and Clinical teams.

Requirements

• Bachelor’s degree; no prior relevant experience is required.
• Accuracy and attention to detail when reviewing and documenting product complaints and adverse-event information.
• Ability to interpret and follow procedures, regulatory requirements, and quality-system documentation.
• Strong written and verbal communication skills.
• Unrestricted United States work authorization is required at hiring and throughout employment; sponsorship is not available for this associate-level role.
• For degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• At least six months of experience processing complaints from intake through investigation.
• Experience in medical devices, pharmaceuticals, biotechnology, or another regulated industry.
• Experience with Medical Device Reporting, vigilance, post-market surveillance, or complaint handling.
• Neuromodulation and Pelvic Health product or therapy experience.
• Experience with Global Complaint Handling systems.

Culture & Benefits

• Onsite work model with no travel required.
• Health, dental, and vision insurance for eligible regular employees.
• Health Savings Account, Flexible Spending Account, life insurance, and disability benefits.
• Paid time off, paid holidays, 401(k) with employer contribution and match, and incentive plans.
• Tuition assistance or reimbursement, Employee Stock Purchase Plan, Employee Assistance Program, and global well-being resources.