Regulatory & Quality Compliance Manager

Experience

Required:

Minimum 2+ years regulatory/compliance experience

We are seeking an experienced Regulatory & Quality Compliance Manager to lead regulatory and quality initiatives in a growing medical device environment. This role will be instrumental in preparing for ISO 13485 certification within the next four months while ensuring continued compliance with FDA and OSHA requirements.

This is a strategic regulatory compliance role — not a traditional warehouse QA position.

• Support development, implementation, and maintenance of an ISO 13485–compliant Quality Management System (QMS)
• Lead documentation control, SOP development, and gap assessments
• Coordinate internal audits and support external certification audits
• Ensure alignment with FDA expectations and ISO standards
• Drive continuous quality improvement initiatives

• Maintain annual FDA establishment registration and device listings
• Ensure compliance with general FDA regulatory requirements
• Manage regulatory documentation and recordkeeping
• Assist in preparation or submission of 510(k) applications (strongly preferred)
• Monitor regulatory updates and implement required changes

• Ensure compliance with current Utah OSHA requirements
• Oversee warehouse and operational safety programs
• Conduct safety audits, risk assessments, and employee training
• Maintain OSHA documentation and reporting

• Minimum 2+ years of experience in regulatory compliance or quality assurance
• Hands‑on experience working within an ISO 13485–compliant QMS
• Working knowledge of FDA regulatory requirements
  
  Experience supporting or managing OSHA compliance
• Strong documentation, organizational, and audit‑preparation skills

• Experience preparing or supporting 510(k) submissions
• Experience participating in ISO certification audits
• Background in medical device regulatory compliance
• $85,000 – $100,000 annually (commensurate with experience)
• Medical insurance
• Paid holidays
• Opportunity for growth within a regulated, expanding organization

Prince Perelson & Associates is an Equal Opportunity Employer and we do not discriminate against applicants due to race, color, religion, sex, national origin, age, disability, genetics, veteran status, or on the basis of disability or any other federal, state or local protected class. All applicants applying for U.S. job openings must be authorized to work in the United States.