Principal Clinical Quality Specialist

Atri Cure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use Atri Cure technologies for the treatment of Afib and reduction of Afib‑related complications. Atri Cure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib.

Atri Cure's Atri Clip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. Atri Cure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long‑standing persistent Afib patients. Atri Cure's cryo

ICE cryo

SPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit  or follow us on Twitter @Atri Cure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

The Principal Clinical Quality Specialist will support the Clinical Affairs Organization in ensuring the quality and compliance of studies conducted within the clinical portfolio. This role will be responsible for leading and proactively driving clinical quality behaviors, accountability, and cross‑functional collaboration (e.g. Clinical Programs, Scientific Affairs, Atri Cure Quality, Regulatory Affairs, Medical Directors, Study Teams, Investigational Trial Sites, and external vendors) with respect to clinical quality assurance activities.

The Principal Clinical Quality Specialist will also drive continuous improvement in adherence to agency regulations and standards, GCP, global industry guidelines, and Atri Cure policies, procedures and processes for the conduct of clinical studies.

• Maintain and monitor Atri Cure clinical processes and procedures for compliance with applicable regulations and industry best practices, driving clinical process improvement projects and initiatives for development, enhancement and implementation of controlled documents (e.g. Standard Operating Procedures (SOPs), Work Instructions (WI) and Templates).
• Support implementation of Quality processes including audit and inspection readiness activities to ensure clinical studies are conducted in compliance with relevant Atri Cure policies, procedures, regional and local regulatory requirements, and global guidelines and standards.
• Support and/or represent the company in clinical audits, coordinating responses with Regulatory Affairs, Atri Cure Quality, Scientific Affairs, legal, and vendors as applicable.
• Identify non‑conformance with requirements, providing suitable recommendations and facilitating ongoing quality improvements using optimal methodologies while maintaining compliance with applicable study protocols, and global regulatory requirements as applicable.
• Lead and contribute to the development and maintenance of Clinical Quality metrics for input into process improvement initiatives and/or presentation to study management and leadership teams.
• Lead the development and delivery of clinical quality compliance‑related training to internal functional groups, providing guidance and ensuring study teams are following targeted SOPs/WIs during a study.
• Assist in the development of GCP audit strategies across clinical programs and/or studies.
• Assist in planning, developing and managing audits of clinical vendors, clinical sites, and/or internal clinical processes, and manage pre/post inspection follow‑up activities (e.g. reports, corrective actions) as applicable.
• Perform reviews of clinical study documentation for data integrity and compliance with GCP guidelines and regulations, including quality control checks of the eTMF to ensure it is inspection ready.
• Assure appropriate oversight of Clinical Software Validation and Supplier/Vendor Qualification/Management and…