Associate MDR/Vigilance Specialist (Medical Devices)

Location: Mounds View, Minnesota, United States of America; minimum 4 days per week onsite

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

Company

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

What you will do

• Document and evaluate product feedback, product analysis results, and complaint information.
• Determine Medical Device Reporting and Vigilance reporting eligibility under U.S. and international regulations.
• Compile complete, accurate, and timely MDR, Vigilance Report, adverse drug experience, and adverse reaction submissions.
• Monitor complaint intake, evaluation, investigation, follow-up, and closure activities.
• Collaborate with internal and external contacts to collect complaint information and develop regulatory reporting processes.
• Track new products, government regulations, and applicable reporting requirements.

Requirements

• Bachelor’s degree with no prior work experience required.
• Degree earned outside the United States must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
• Must possess unrestricted U.S. work authorization at the time of hire and throughout employment.
• Ability to work onsite at least four days per week and interact independently with computers and coworkers.

Nice to have

• Education in healthcare, sciences, or biomedical engineering.
• Technical writing experience and the ability to create clear, accurate documentation.
• Experience with Global Complaint Handling systems and medical device quality or compliance activities.
• Knowledge of cardiac anatomy, physiology, and related medical conditions.
• Proficiency with Microsoft Office, SAP, Siebel, Oracle Clinical, and other business systems.

Culture & Benefits

• Full-time regular employment with health, dental, and vision insurance.
• Health Savings Account, Flexible Spending Account, life insurance, and disability coverage.
• Paid time off, paid holidays, employee assistance, and retirement benefits including a 401(k) with employer contribution and match.
• Tuition assistance or reimbursement and a global well-being program.
• Employee Stock Purchase Plan and incentive plans.