Senior Compliance & Audit Lead — Medical Devices

USA-MiniMed Distribution Corp. 1018; Los Angeles (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

USA-MiniMed Distribution Corp. 1018 is seeking a Principal Compliance/Audit Specialist to strengthen regulatory compliance, audit readiness, and quality system effectiveness in a regulated medical device environment.

The role leads audits, risk evaluations, and CAPA activities while partnering with cross-functional teams to close gaps and implement corrective actions. The ideal candidate has extensive auditing and regulatory experience, experience with FDA and ISO 13485, and a passion for

Qualifications

• Experience in medical device quality and regulatory compliance.
• Auditing, risk assessment, and CAPA effectiveness.
• Experience supporting regulatory inspections and driving readiness.

Responsibilities

• Coordinate internal/external risk assessments and audits per regulatory standards.
• Oversee audits, investigations, and interview processes; report outcomes.
• Interpret applicable regulations for products, processes and procedures.
• Counsel stakeholders on regulatory requirements as needed.
• Ensure compliance with agencies and resolve questions or concerns.
• Analyze audit data and present findings to leadership for corrective actions.
• Develop programs and training to raise awareness of compliance policies.

Skills

Auditing

Regulatory compliance

CAPA effectiveness

Stakeholder management

Regulatory inspections

Education

Bachelor's degree

Advanced degree

Job description

USA-MiniMed Distribution Corp. 1018 is seeking a Principal Compliance/Audit Specialist to strengthen regulatory compliance, audit readiness, and quality system effectiveness in a regulated medical device environment.

The role leads audits, risk evaluations, and CAPA activities while partnering with cross-functional teams to close gaps and implement corrective actions. The ideal candidate has extensive auditing and regulatory experience, experience with FDA and ISO 13485, and a passion for