Sr. Clinical Compliance Manager, Transcatheter Heart Valve

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 Sr. Clinical Compliance Manager for our THV team, you will be responsible leading the development, implementation, and continuous improvement of Clinical Compliance processes. 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 will make an impact:

• Develop and manage comprehensive BU clinical compliance processes and workflows to ensure clinical compliance in accordance with regulatory and company requirements
• Identify and lead business improvement solutions for Clinical study processes, including creating reviewing and recommending changes to procedures and processes, to or improve operation, efficiencies, and drive clinical compliance
• Lead internal cross-functional compliance assessments with a focus on adherence with applicable regulatory and company guidelines (e.g., internal Standard Operating Procedures and Instructions, GCP, and best practices)
• Lead compliance assessments of external research partners (e.g., research institutions, clinical suppliers)
• Develop program for the ongoing review of external regulatory audit findings (e.g., FDA warning letters, 483’s, CAPA)
• Train and assess team members in conducting internal and external assessments (e.g. clinical site, clinical suppliers, internal systems) and document performance as a basis for qualification
• Develop and deliver training programs for stakeholders (e.g., clinical groups and Clinical Compliance) on best practices, trends, regulatory requirements, published guidance, policy and procedure updates
• Develop training, coach, and guide team members on clinical compliance procedures and regulations
   

What you will need (Required):

• Bachelor's Degree in related field PLUS 10 years of previous related clinical monitoring, quality assurance/control, or regulatory compliance experience from a sponsor or CRO
• Master’s Degree in related field PLUS 8 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 III (FDA) cardiac or implantable devices
• 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

Additional skills:

• Recognized as an expert in own area with specialized depth and breadth of expertise
• Expert understanding of related aspects of Clinical Compliance processes and/or systems
• Expert knowledge and understanding of diverse and applicable regulations and standards relevant to medical devices
• Proven successful project management skills
• Proven expertise in Microsoft Office Suite, including advanced Excel and Clinical Compliance systems
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship managemen