Sr. Clinical Quality Auditor - Shockwave Medical

📋 Description

• Lead and support GCP and compliance audits across internal teams, investigative sites, and external
• Develop audit management plans, risk-based audit strategies, and audit plans for ongoing clinical
• Conduct internal system audits and external site and vendor audits per GCP and regulatory
• Lead initial and ongoing audits of clinical study vendors (CROs, imaging core labs, central labs
• Document and communicate audit findings, provide resolution recommendations, and verify CAPAs are
• Identify, assess, and escalate site, vendor, and study-related compliance issues; support

🎯 Requirements

• Bachelor’s degree or equivalent in a scientific field.
• 5+ years of experience in clinical research, quality assurance, or related field.
• Experience auditing clinical research vendors and investigative sites.
• Experience interacting with regulatory authority inspectors and supporting inspections.
• Proven experience revising SOPs, procedures, and quality documentation.
• Strong knowledge of GCP and device regulations including FDA, ISO 14155, and MDR.

🎁 Benefits

• Fully remote position within the United States.
• Base salary range: $91,000–$147,200 USD.
• Eligibility to participate in a long-term incentive program.
• Retirement benefits including 401(k) plan participation.
• Paid time off including vacation, sick time, holidays, and family leave.