Anteris Technologies

• Help support the execution of clinical trials while advancing clinical evidence and valve science. • Provide procedural and clinical trial case support, contribute to trial enrolment, and identify ongoing educational opportunities for heart team members and the broader referring community. • Collaborate closely with Clinical Affairs, Regulatory Affairs, R&D, Quality and Marketing to support optimal clinical outcomes and achieve enrolment objectives aligned with the company’s goals and strategy. • Attend assigned clinical cases and support the heart team with preparation and loading of the DurAVR valve. • Maintain in-depth knowledge of existing DurAVR clinical data and the evolving structural heart evidence landscape. • Uphold the company’s AORTIC values: Accountability, Objectivity, Respect, Teamwork, Integrity and Courage.

• Lead the end‑to‑end screening process, ensuring all pre‑procedure assessments (e.g. CT, echo, labs, risk scoring) are completed accurately and on time across participating sites. • Lead scientific and operational evaluation of inclusion/exclusion criteria, providing clear, defensible decisions on subject eligibility in alignment with the protocol and regulatory expectations. • Partner with investigators, coordinators, and field teams to drive screening performance, troubleshoot barriers, and ensure consistent application of screening criteria. • Collaborate with cardiologists, study coordinators, and clinical teams to prioritize potential participants. • Provide clinical insights to support case planning and feasibility discussions. • Ensure compliance with GCP, FDA, and trial protocols during all screening activities. • Lead live screening meetings to review cases and discuss patient eligibility trends. • Ensure completeness, accuracy, and protocol compliance of all screening‑related data; identify trends, gaps, and risks requiring corrective action.

• Successfully complete the Anteris internal training programme, including demonstrating competency in CT and echocardiographic imaging, the applicable Instructions for Use, procedural best practices, clinical evidence, approved product messaging and the competitive landscape. • Interface with clinical trial sites, demonstrating expertise in all technical aspects of TAVI clinical case support, training and education, customer service and communication. • Demonstrate competency in all procedural aspects of DurAVR® THV case support, including valve preparation and loading, device delivery and implantation, complication mitigation and troubleshooting, in accordance with the clinical trial protocol and established best practices. • Demonstrate a thorough understanding of the approved DurAVR clinical trial protocol, including inclusion and exclusion criteria and requirements for pre- and post-procedure imaging and clinical data. • Demonstrate proficiency in pre-case planning, CT analysis and pre- and post-procedure recommendations to support optimal clinical outcomes. • Maintain in-depth knowledge and understanding of existing DurAVR clinical data and the evolving structural heart evidence landscape. • Support the Clinical and Regulatory Operations teams with site communications, data compliance activities, screening review efficiency and site submission requirements. • Attend assigned clinical cases and support the heart team with preparation and loading of the DurAVR valve. • Provide education and guidance to physicians and site personnel regarding the identification of appropriate study participants and support complete and accurate patient screening and enrolment documentation. • Track patient screening pathway activity and routinely provide site-level metrics related to screening progress and trial enrolment. • Identify operational improvement opportunities at the site level and recommend strategies to accelerate enrolment, improve efficiency and appropriately advance therapy adoption. • Maintain accurate and timely documentation of case support, site activity, training and other required clinical trial information. • Comply with all applicable Australian regulations, clinical trial requirements, company policies and site-specific procedures. • Uphold the company’s AORTIC values: Accountability, Objectivity, Respect, Teamwork, Integrity and Courage.

• Support clinical research, physician engagement, global regulatory strategy, and advancement of therapies. • Roles include Clinical Project Manager, Clinical Research Associate, Clinical Research Scientist, Clinical Specialist, and Regulatory Affairs Specialist.

• Perform detailed review and analysis of cardiac CT scans for patients being considered for enrollment in global clinical studies. • Evaluate imaging data to support patient eligibility and screening decisions. • Assess anatomical characteristics relevant to TAVR procedural planning, including aortic annulus sizing, vascular access, calcium distribution, coronary heights, valve morphology, and other structural heart considerations. • Utilize advanced imaging platforms, including 3Mensio or equivalent software, to perform measurements and generate screening reports. • Identify and escalate imaging findings that may impact patient eligibility, procedural planning, or study participation. • Maintain accurate documentation of imaging assessments, recommendations, and screening outcomes. • Collaborate with Clinical Science, Clinical Operations, Therapy Development, and Field Clinical teams across Europe, North America, and Asia-Pacific to support timely patient screening and enrollment activities. • Participate in multidisciplinary case review discussions, screening conferences, and physician review meetings. • Prepare and present patient imaging analyses during screening conferences and physician case planning sessions. • Support protocol compliance and consistency in imaging review processes across participating global clinical sites. • Contribute to the development, refinement, and standardization of imaging review workflows and best practices. • Serve as a clinical imaging resource for investigators, physicians, study coordinators, and site personnel regarding imaging requirements and screening processes. • Partner with physicians and Field Clinical Specialists to facilitate patient-specific procedural planning discussions. • Communicate imaging findings clearly and effectively to both internal and external stakeholders. • Assist clinical sites in obtaining complete, high-quality CT imaging submissions. • Ensure all activities are performed in accordance with applicable global regulatory requirements, ICH-GCP guidelines, company policies, and quality system requirements. • Maintain patient confidentiality and data privacy in accordance with GDPR, applicable local privacy regulations, and study requirements. • Support audit readiness, inspection preparedness, and documentation compliance. • Participate in continuous improvement initiatives related to imaging review, patient screening, and clinical operations.

Role Description We are seeking a Regulatory Affairs Specialist that will lead and perform regulatory submission/approval activities for the company’s medical device products as directed with primary responsibility for FDA. This individual will provide clinical study regulatory support, some international (outside North America) regulatory submission support, coordinate with FDA and international regulators on submission reviews and approvals and ensure compliance with required regulations and established corporate standards. - Define regulatory requirements necessary for regulatory approval of products in North America. - Complete North American regulatory assessments as required to support projects and provide direction to project teams to support new product development and product modifications as required. - Provide direction on application of external standards for all projects as required. - Maintain all regulatory documentation to ensure availability for audits and preparation of submission packages for North America. - Lead regulatory activities for product field corrective actions to maintain compliance and ensure that product approvals are properly maintained, and product re-submissions are properly managed. - Assist in the development and implementation of required post-market surveillance. - Maintain all regulatory documentation to ensure availability for audits and preparation of submission packages for international markets. - Coordinates timely renewal of certificates, licenses, and registrations. - Assist in creation of product labeling and instructions for use [package inserts] by collaborating with cross-functional business partners. - Review and approve marketing literature and other items for compliance with relevant regulatory requirements. - Assist in the development and implementation of the Physician Payments Sunshine Act. - Author, review, and/or approve internal operating procedures related to regulatory affairs. - Knowledge of Quality Systems Manual, Product Development, QSR & MDD, Complaint Handling. Qualifications - A bachelor's degree in a science or engineering concentration is required. - Minimum of 5 years of experience in Regulatory Affairs. - Requires 5+ years' medical device industry experience including authoring PMA, IDE, and 510(k) submissions, preferably in the cardiovascular field. - Experience with Class III devices required. - Experience with Health Canada and international market submissions a plus. - Strong working knowledge and experience with quality systems regulations and guidelines, ISO 13485, GMP, Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR) and FDA regulatory requirements. - Must have ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel. - Demonstrated ability in project management skills in order to plan, conduct and implement system assessments and robust submissions. - RAC Certification preferred. - Microsoft Office software experience. Requirements - Leadership: Foster teamwork, lead courageously, champion change. - Motivation: Drive for results, work commitment. - Self-Management: possess integrity, exhibit honesty, demonstrate adaptability. - Interpersonal: value diversity, develop relationships. - Communication: communicate openly, listen to others. - Thinking: demonstrate sound judgment, assess strategically, analyze issues. Benefits - Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies. - Collaborative and dynamic work environment with a culture of innovation and excellence. - Competitive compensation package, including salary, performance-based bonuses, and stock options for full-time employees. - Career development opportunities and a chance to be part of a growing company that values its employees.