Principal Regulatory Affairs Specialist

Über diese Stelle

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 world’s 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.

We are seeking a Principal Regulatory Affairs Specialist to lead and execute regulatory activities supporting the development, clinical investigation, approval, and lifecycle management of Anteris’ medical device products across Europe. This individual will serve as a senior regulatory subject matter expert, with primary responsibility for EU regulatory strategy and submissions for Class III cardiovascular devices.

The Principal Regulatory Affairs Specialist will work closely with Clinical Affairs, Quality, R&D, Medical Affairs, and other cross-functional partners to support clinical studies, CE marking activities, product changes, and post-market regulatory requirements. This role will also coordinate directly with Notified Bodies, Competent Authorities, Ethics Committees, and other regulatory stakeholders, while providing support for submissions in additional international markets as needed.

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.

Main Responsibilities

• Develop and execute European regulatory strategies for new products, clinical investigations, product modifications, and lifecycle management activities, with a primary focus on Class III cardiovascular devices.

• Define applicable regulatory requirements under the EU Medical Device Regulation, MDR (EU) 2017/745, and provide clear guidance to cross-functional project teams.

• Lead the preparation, review, and submission of technical documentation and other materials required to support CE marking, clinical investigations, substantial modifications, and product registrations.

• Serve as a primary regulatory contact with Notified Bodies, Competent Authorities, Ethics Committees, and other European regulatory stakeholders. Coordinate responses to questions and requests for additional information through approval or resolution.

• Provide regulatory support for European clinical investigations, including clinical investigation applications, study amendments, safety reporting, and required regulatory or Ethics Committee communications.

• Partner with Clinical Affairs and Medical Affairs to ensure alignment among clinical evidence, clinical evaluation, post-market clinical follow-up, and regulatory strategies.

• Assess proposed product, manufacturing, labeling, supplier, and process changes to determine regulatory impact and required notifications or submissions.

• Provide direction regarding the identification and application of relevant standards, Common Specifications, guidance documents, and regulatory expectations.

• Support the development and maintenance of technical documentation, including the Clinical Evaluation Report, Summary of Safety and Clinical Performance, risk management documentation, post-market surveillance plans and reports, and post-market clinical follow-up documentation.

• Lead or support regulatory activities related to vigilance reporting, field safety corrective actions, product recalls, and communications with applicable European authorities.

• Collaborate with cross-functional partners to develop and maintain compliant product labeling, instructions for use, and promotional materials.