Clinical Quality Assurance Manager

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Shockwave Medical

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Description

• Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. • Establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. • The Clinical Quality Assurance Manager will provide GCP and compliance-related oversight and audit of internal and external Clinical Studies in process. • Support and update procedure compliance with applicable regulations and oversee clinical affairs initial and ongoing vendor audits as needed.

Requirements

• Bachelor’s degree required • BS degree in scientific field of study is highly preferred but not required • 10 years’ experience directly supporting clinical research or relevant experience in medical/scientific area • Minimum 1 year in a role directly managing trials and projects, 2-3 years preferred • 5+ years of experience in Quality in a related industry • 2+ years of people management or relevant experience • Experience conducting audits of vendors and investigative sites • Experience hosting and interacting with regulatory authority inspectors • Experience preparing and supporting clinical study sites undergoing regulatory authority inspections • Experience authoring and revising SOPs and procedures • Thorough knowledge and application of Good Clinical Practice (GCP) i.e. FDA, ISO, MDR • Knowledge and experience in supporting device pre- and/or post-market clinical studies • Medical Device experience is preferred • Ability to travel up to 30%-40% of time domestically and internationally • Excellent written and verbal communication skills • Basic understanding of peripheral and coronary artery disease and therapies preferred • ACRP or SOCRA certification preferred • Ability to work in a fast-paced environment while managing multiple priorities across multiple projects • Operate as a team and/or independently while demonstrating flexibility to changing requirements • High attention to detail and accuracy

Benefits

• Medical • Dental • Vision • Pre-tax and Roth 401k options with a fully vested match • Short-Term and Long-Term Disability • Life Insurance • Employer contribution toward Health Savings Account (HSA) • Competitive PTO balance • ESPP • Calm App • Pet Insurance • Student Loan Refinancing • Spot Bonus awards