Sr. Clinical Quality Auditor - Shockwave Medical

Job Description

• This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Clinical Quality Auditor – Shockwave Medical based in United States. This fully remote role provides critical quality oversight across clinical studies supporting innovative medical device therapies. You’ll lead and support GCP and compliance audits across internal teams, investigative sites, and external clinical vendors. The position plays an important role in maintaining regulatory readiness and ensuring clinical research activities meet global quality standards. You’ll work closely with clinical, quality, regulatory, and external partners across multiple studies and projects. The role combines independent audit leadership, compliance expertise, procedural improvement, and inspection readiness. It offers the opportunity to influence clinical quality systems while working in a fast-paced, highly regulated MedTech environment. Success requires sound judgment, meticulous attention to detail, strong communication, and the ability to operate confidently with limited supervision.
• Accountabilities: Serve as a Clinical Quality Auditor Lead for clinical trials, supporting project teams in maintaining compliance with applicable national and international medical device regulations and GCP requirements. Support the development of audit management plans, risk-based audit strategies, and audit plans for ongoing clinical studies. Conduct internal system audits and external investigative site and vendor audits in accordance with GCP and applicable regulatory expectations. Lead initial and ongoing audits of clinical study vendors, including CROs, imaging core laboratories, central laboratories, and other third-party partners. Document and communicate audit findings to management, provide recommendations for resolution, and verify that appropriate corrective and preventive actions are implemented and documented. Identify, assess, and escalate site, vendor, and study-related compliance issues as appropriate. Support regulatory authority inspections and assist clinical study sites and internal teams with inspection preparation and readiness activities. Develop, review, and revise standard operating procedures, work instructions, forms, templates, and other quality documentation. Participate in the development and implementation of departmental procedures and continuous quality improvement initiatives. Deliver or support training programs covering GCP, inspection readiness, and other clinical quality topics. Maintain strong working relationships with internal stakeholders, external vendors, clinical research teams, and regulatory partners. Manage multiple audits and quality initiatives while adapting to changing priorities, timelines, and project requirements. Work independently once projects are assigned while exercising sound judgment and maintaining consistent communication with relevant stakeholders. Requirements: Bachelor’s degree or equivalent experience in a scientific discipline or related field. 5+ years of experience directly supporting clinical research, quality assurance, or a relevant medical/scientific function. Demonstrated experience conducting audits of clinical research vendors and investigative sites. Experience interacting with regulatory authority inspectors and supporting clinical study sites through regulatory inspections. Proven experience reviewing and revising SOPs, procedures, work instructions, or related quality documentation. Thorough knowledge and practical application of Good Clinical Practice (GCP) and relevant medical device requirements, including FDA regulations, ISO 14155, and MDR. Experience supporting medical device pre-market and/or post-market clinical studies. Medical device industry experience strongly preferred, ideally with exposure to cardiovascular therapies or clinical research. Basic understanding of peripheral and coronary artery disease and related therapies preferred. ACRP or SOCRA certification is preferred. Strong independent thinking, planning, organizational, and problem-solving capabilities. Excellent written and verbal communication skills, with the ability to communicate effectively with both technical and non-technical stakeholders. Strong teamwork and collaboration skills, combined with the ability to operate independently and influence stakeholders across functions. High attention to detail and accuracy, with a strong commitment to quality and compliance. Ability to work effectively in a fast-paced environment while managing multiple priorities and projects. Flexible and adaptable approach to changing business and regulatory requirements. Willingness and ability to travel approximately 30–40% domestically and internationally. Benefits: Fully remote position within the United States. Anticipated base salary range of $91,000–$147,200 USD. Eligibility to participate in a long-term incentive program. Retirement benefits including pension and 401(k) savings plan participation, subject to applicable plan terms. 120 hours of vacation per calendar year. 40 hours of sick time per calendar year, with higher allocations in certain states. 13 paid holidays, including floating holidays, per calendar year. Up to 40 hours of Work, Personal and Family Time annually. Up to 480 hours of parental leave within one year following birth, adoption, or foster care placement. Bereavement leave for eligible family circumstances. Caregiver leave of up to 80 hours in a rolling 52-week period. 32 hours of volunteer leave per calendar year. 80 hours of military spouse time-off per calendar year. Opportunities to contribute to innovative medical device clinical research and strengthen expertise in global GCP and regulatory compliance. Collaborative environment with exposure to clinical quality, regulatory, and external research partners.
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