Clinical Compliance Manager

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

As the Clinical Compliance Manager, you will conduct audits of sites, vendors, and Clinical Affairs and provide guidance on course corrections. Please note that this role is a subject matter expert (SME) role and will not have any direct reports nor managerial duties involved.

How you’ll make an impact:

• Lead in the evaluation of all audit findings (e.g., internal, site, vendor) from beginning to end, to determine severity, i.e., critical, major or minor, and provide advice and guidance in developing corrective and preventative course of action to resolve audit findings
• Lead and conduct audits of (a) EW’s internal clinical processes (b) clinical sites and (c) vendor audits - including complex audits across business units and regions, budgeting, scheduling, and staffing (internal and/or CROs). Develop and execute audit plans and schedules for compliance audits of assigned clinical study projects
• Lead continuous process improvement of efficiency and accuracy of processes and procedures. Assess and identify compliance risk based on clinical quality data of observations
• Train and assess team members in conducting clinical site, vendor, internal audits and document performance as a basis for qualification
• Develop and deliver training programs for clinical groups and Clinical Compliance on best practices, trends, regulatory requirements and updates and published guidance, policy and procedure updates, etc.
• Provide guidance on Clinical Standard Operating Procedures (SOP's) to Edwards Business Units to ensure compliance with FDA regulations, GCP and ISO
• Guide business unit representatives on clinical compliance during external audits conducted by regulatory agencies
• Review and provide feedback on clinical protocols, CRFs, Clinical Study Reports and other clinical documents
• Other incidental duties assigned by leadership

What you’ll need (required):

• Bachelor’s Degree in related field
• Minimum 7 years of previous related clinical monitoring, quality assurance/control, or regulatory compliance experience from a sponsor or CRO
• Ability to travel up to 25% nationwide

What else we look for (preferred):

• Experience with working in a medical device or regulated industry
• Experience with Class I (FDA) cardiac or implantable devices

Additional skills:

• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Excellent written and verbal communication skills and interpersonal relationship skills
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Good knowledge and understanding of diverse and applicable regulations and standards relevant to medical devices (e.g., 21 CFR Part 11/50/54/56/ 801/803/806/807/820/812/814/821/822, ISO 14155; ICH GCPs)
• Good knowledge and understanding of global regulatory requirements for new products or product changes
• Good knowledge of clinical trials and quality systems (e.g., root cause analysis, trend analysis, and CAPA)
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment