Principal Regulatory Affairs Specialist

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. Review marketing and scientific communications for compliance with applicable European regulatory requirements and approved product claims. Support product registrations, certificate renewals, licenses, and regulatory maintenance activities across European and other international markets. Maintain complete, accurate, and audit-ready regulatory documentation, including records required for Notified Body assessments and regulatory inspections. Author, review, and approve regulatory procedures, work instructions, and other controlled documents. Monitor changes in European regulations, guidance, standards, and regulatory practices; assess potential business impact and communicate requirements to appropriate stakeholders. Provide regulatory leadership, mentorship, and strategic guidance to colleagues and project teams. Skills, Knowledge, Experience & Qualifications Bachelor’s degree in science, engineering, life sciences, or a related discipline required. An advanced degree is preferred. Minimum of five years of progressively responsible medical device Regulatory Affairs experience, including substantial experience with European regulatory submissions and approvals. Demonstrated experience supporting Class III medical devices required; cardiovascular, structural heart, or implantable device experience strongly preferred. Strong working knowledge of MDR (EU) 2017/745, ISO 13485, ISO 14971, ISO 14155, applicable European guidance, and relevant international standards. Experience preparing technical documentation and supporting CE marking activities, including direct interaction with Notified Bodies. Experience supporting European clinical investigations, including submissions to Competent Authorities and Ethics Committees, strongly preferred. Knowledge of clinical evaluation, post-market surveillance, post-market clinical follow-up, vigilance reporting, and field safety corrective action requirements. Familiarity with EUDAMED, European Authorized Representative requirements, and Unique Device Identification requirements preferred. Experience supporting international regulatory submissions outside Europe is an advantage. Demonstrated ability to interpret complex regulatory requirements and translate them into clear, practical direction for cross-functional teams. Strong project management skills, including the ability to manage multiple priorities, submission timelines, and regulatory deliverables in a fast‑paced environment. Excellent written and verbal communication skills, with the ability to prepare clear, concise, and persuasive regulatory documentation. Strong interpersonal skills and the ability to communicate effectively with colleagues, senior leaders, external partners, and regulatory authorities across different countries and cultures. Proficiency with Microsoft Office applications and electronic document management systems. Regulatory Affairs Certification, RAC, or an equivalent European regulatory qualification preferred. Professional fluency in English required; proficiency in an additional European language is an advantage. Success Profile Provides objective, evidence‑based regulatory guidance and demonstrates sound judgment. Takes accountability for regulatory deliverables, timelines, and submission quality. Builds trusted, respectful relationships with cross‑functional teams and external regulatory stakeholders. Works collaboratively while demonstrating the courage to raise risks, challenge assumptions, and recommend appropriate actions. Operates with integrity, adaptability, and a strong commitment to quality and compliance. Thinks strategically while maintaining close attention to technical and regulatory detail. What We Offer The opportunity to make a meaningful impact on the treatment of aortic stenosis by advancing groundbreaking structural heart therapies. A collaborative, international work environment grounded in scientific innovation, integrity, and excellence. The opportunity to work with experienced colleagues across Europe, the United States, and Australia. Competitive compensation, performance‑based incentives, and equity participation, where applicable and subject to local requirements. Professional development opportunities and the chance to grow with a company working to redefine expectations in structural heart care. 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. We have 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. #J-18808-Ljbffr Anteris Technologies