Regulatory & Quality Compliance Manager

PrincePerelson and Associates; Lindon (UT); On-site; USD 85,000 - 100,000; Full time

Benefits offered by this job

Medical insurance

Paid holidays

Opportunity for growth

Job summary

A leading staffing agency is seeking a Regulatory & Quality Compliance Manager in Lindon, UT to lead regulatory and quality initiatives in a medical device environment. This role focuses on ISO 13485 certification and ensuring compliance with FDA and OSHA regulations. Candidates should have a minimum of 2 years' regulatory compliance experience and strong documentation skills. The position offers a salary range of $85,000 – $100,000 annually with potential for growth within the organization.

Qualifications

• Minimum 2+ years of experience in regulatory compliance or quality assurance.
• Hands‑on experience with ISO 13485-compliant QMS.
• Working knowledge of FDA regulatory requirements.

Responsibilities

• Support development of ISO 13485-compliant Quality Management System.
• Lead documentation control and coordinate internal audits.
• Ensure compliance with FDA and OSHA requirements.

Skills

Regulatory compliance

Quality assurance

Documentation skills

Organizational skills

Job description

Experience Required: Minimum 2+ years regulatory/compliance experience

Position Overview

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.

Key Responsibilities

1. ISO 13485 Compliance & Certification Readiness

• 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

2. FDA Regulatory Oversight

• 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

3. OSHA Compliance (Utah)

• 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

Qualifications

Required

• 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 requirementsExperience supporting or managing OSHA compliance
• Strong documentation, organizational, and audit‑preparation skills

Preferred

• 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

PrincePerelson & 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.