Senior Clinical Quality Specialist

Job Description

Job Description

Salary :

Anteris Technologies is a global structural heart company dedicated to revolutionizing cardiac care.With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the worlds first biomimetic TAVR valve, DurAVR THV. This cutting-edge valve, incorporating our proprietary ADAPT anti-calcification technology, is designed to mimic the natural function of a healthy heart valve.

The Sr. Clinical Quality Specialist is responsible for establishing, managing, and maintaining quality systems that ensure all clinical trial activities meet the highest standards of compliance, integrity, and reliability. This individual will play a key role in supporting global IDE trials for Class III medical devices, ensuring adherence to GCP, ISO 13485, and applicable regulatory requirements. The role requires expertise in clinical quality oversight, vendor management, and continuous process improvement to enable the successful execution of complex clinical programs.

At Anteris Technologies, you'll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.

Key Responsibilities :

Clinical Quality Oversight :

• Oversee quality assurance activities related to clinical trials, ensuring compliance with ISO 14155 and global regulatory standards.
• Review and approve clinical trial documentation (protocols, CRFs, SOPs, monitoring plans, etc.) for adherence to quality standards.
• Partner with internal teams and external vendors to ensure consistent application of quality requirements throughout trial execution.

Quality Management System (QMS) :

Auditing & Vendor Management :

Risk Management & CAPA :

Training & Continuous Improvement :

Skills, Knowledge, Experience, Qualifications

What We Offer :

Health and Wellness Offerings :

Note : We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and / or travel regulations.

Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. Wehave a clear vision : to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization.Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.

remote work