Senior VP, Clinical, Regulatory, and Quality
 Anteris Technologies

Position Overview

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Anteris Technologies is a US-based structural heart startup addressing the aortic valve disease market with the first valve that restores physiological hemodynamics across the aortic valve. Anteris went public on the NASDAQ with an $88.8M IPO in December 2024. We are now hiring our Senior VP of Clinical, Regulatory, and Quality.

 

• Annual General Meeting: Anteris 2024 Annual Meeting Video

• EFS Data: Biomimetic Transcatheter Aortic Heart Valve Offers New Option for Aortic Stenosis Patients

 

We have partnered with David St. Denis, President of Anteris Technologies, to hire our Senior Vice President of Clinical, Regulatory, and Quality. This is a US-based, remote leadership position that will serve as the face of the company to external clinical, regulatory, and quality stakeholders while leading the clinical team in the execution of their IDE trial, the regulatory team through their PMA submission in 2027, and quality team to ensure continued compliance as the company scales production. This position will work closely with Therapy Development to engage KOLs globally in the trial and generate commercial interest ahead of a 2028 product launch.

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Responsibilities

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​​Clinical Operations (Trial Management)

• Provide strategic leadership and oversight for the planning, execution, and management of global clinical trials to support regulatory approvals.

• Drive operational excellence, ensuring trials are conducted efficiently, ethically, and in compliance with regulatory requirements (e.g., FDA, EMA, PMDA).

• Develop and oversee clinical development strategies that align with business objectives and support market access.

• Lead cross-functional collaboration with R&D, Medical Affairs, and Commercial teams to integrate clinical insights into product development.

• Manage partnerships with CROs, investigators, and key opinion leaders (KOLs) to ensure successful trial execution.

 

Regulatory Affairs

• Develop and execute global regulatory strategies to support new product approvals and market expansions.

• Oversee the preparation, submission, and maintenance of regulatory filings (e.g., IDE, PMA, CE Mark, 510(k), MDR submissions).

• Maintain strong relationships with regulatory agencies (e.g., FDA, EMA, TGA, NMPA) to influence and anticipate regulatory changes.

• Ensure the organization stays ahead of evolving regulatory landscapes and proactively mitigates risks.

• Provide leadership for regulatory intelligence and policy advocacy to support business objectives.

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Quality Assurance & Compliance

• Oversee global quality systems, ensuring compliance with ISO 13485, FDA QSR, EU MDR, and other applicable regulations.

• Partner with Quality leadership to ensure robust design control, risk management, CAPA, and post-market surveillance programs.

• Drive a culture of quality and continuous improvement, ensuring the highest standards in product development and manufacturing.

• Lead quality audits and inspections, working closely with regulatory bodies and internal teams to maintain compliance.

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Leadership & People Management

• Provide visionary leadership to a global, cross-functional team across Clinical, Regulatory, and Quality.

• Drive organizational development, ensuring the team has the right talent, structure, and resources for success.

• Foster a culture of collaboration, innovation, and accountability, ensuring alignment with corporate goals.

• Act as a senior advisor to the executive team on risk management, clinical development strategy, and regulatory pathways.

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Qualifications & Competencies 

• 15+ years of leadership experience in the medical device industry, with a focus on Class III cardiovascular/structural heart devices.

• Deep expertise in Clinical Operations and/or Regulatory Affairs; strong understanding of Quality Management.

• Proven track record of leading global clinical trials, driving regulatory approvals, and managing quality/compliance in highly regulated markets.

• Experience with FDA, EMA, and other international regulatory agencies.

• Strong people and process management skills, with a history of scaling teams and optimizing operations.

• Ability to influence and engage with executive leadership, regulatory authorities, and external stakeholders.

• Strategic thinker with a data-driven approach, strong business acumen, and a commitment to patient safety and innovation.

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Company Overview 

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Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. 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 sought 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.