Anteris Technologies

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.

• Successfully complete internal training program, including competency with CT and echo imaging, internal IFU, best practices, marketing messaging, clinical evidence, and competitive. • Interface with clinical trial sites, demonstrating expertise and key competencies in all technical aspects of TAVI clinical case support, training & education, customer service and communication skills. • Demonstrate competency and expertise in all procedural aspects, including valve loading & preparation and device delivery and implantation according to established best practices, complication mitigation and troubleshooting techniques for DurAVR THV. • Demonstrate proficiency and understanding of all aspects of the approved DurAVR clinical trial protocol, including inclusion & exclusion criteria, and accuracy in obtaining any required imaging and pre & post procedural data. • Demonstrate proficiency in pre-case planning, CT analysis and pre & post procedure recommendations to ensure optimal clinical outcomes. • In-depth knowledge and understanding of existing DurAVR clinical data. • Support the Clinical & Regulatory Operations team, assisting with site communications, data compliance activity, screening review efficiency and site submission efficiency. • Attend clinical cases, supporting the heart team with device prep and loading of the DurAVR valve in each assigned case. • Provision of education and guidance to physicians and site staff in identifying appropriate study patients and assist site in ensuring complete patient screening and enrollment information. • Track all patient pathway screening process activity, routinely providing metrics per site on screening and progress of enrollment. • Identify operational improvement opportunities at the site level and recommend programs for enrollment acceleration, improved efficiency, and appropriate expanded therapy advancement tools and strategies. • Uphold the company AORTIC values: Accountability, Objectivity, Respect, Teamwork, Integrity, and Courage.