Regulatory Affairs Specialist I (Medtech)

TL;DR

Regulatory Affairs Specialist I (Medtech): Managing routine submissions and documentation for regulatory agencies with an accent on FDA and EU MDR compliance. Focus on coordinating product registrations, maintaining regulatory files, and ensuring strict adherence to ISO standards.

Location: Fraser, MI, US (Hybrid: 3-4 days at home)

Salary: $75,280.00 - $94,100.00 annually + 4% target bonus

Company

hirify.global provides hospitals and life science institutions with products and solutions for intensive care, cardiovascular procedures, operating rooms, and sterile reprocessing.

What you will do

• Collect and manage documentation for routine submissions to regulatory agencies.
• Coordinate product registration, license renewals, and updates with global colleagues.
• Maintain regulatory files and tracking databases to ensure timely submissions.
• Support Field Correction and Recall activities.
• Participate in and support internal and third-party audits.
• Assist with documentation and activities related to EU MDR, PMA, and 510(k) submissions.

Requirements

• Bachelor's Degree in a Scientific/Engineering discipline or equivalent experience in a regulated industry.
• Strong understanding of FDA 21CFR Part 820 QMSR, EU MDR, MDSAP, CMDR, and ISO 13485.
• Proficiency in Adobe Professional and MS Office (Word/Excel).
• Ability to multi-task and handle multiple projects in a fast-paced environment.
• Must be based in the United States.

Culture & Benefits

• Comprehensive Health, Dental, and Vision insurance.
• 401k plan with company match.
• Paid Time Off and Parental/Caregiver Leave.
• Tuition Reimbursement.
• Wellness initiatives and Health Assistance Resources.
• Commuter benefits and life insurance.