Regulatory & Quality Compliance Lead — ISO 13485 Readiness

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

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.