Clinical & Regulatory Affairs

Job description

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. Anteris Technologies is advancing innovative structural heart technologies designed to redefine expectations in the treatment of aortic stenosis. Our Clinical and Regulatory Affairs teams play a critical role in supporting clinical research, physician engagement, global regulatory strategy, and the advancement of breakthrough therapies through development and commercialization. We are interested in connecting with professionals with the following experience: - Clinical operations - Clinical monitoring - Physician support - Field clinical education - Global regulatory compliance, or - Clinical trial management within the medical device industry. Roles in Clinical & Regulatory Affairs include: - Clinical Project Manager - Clinical Research Associate - Clinical Research Scientist - Clinical Specialist - Regulatory Affairs Specialist Candidates with experience supporting Class III medical devices, structural heart therapies, cardiovascular technologies, or global clinical studies are especially encouraged to apply. Successful candidates are collaborative, adaptable, organized, and comfortable operating within fast-paced, cross-functional environments. This is an opportunity to contribute directly to meaningful innovation while helping bring transformative therapies to patients worldwide. **What We Offer:** - 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. - Career development opportunities and a chance to be part of a growing company that values its employees. **Health and Wellness Offerings:** - Medical, Dental, and Vision Plans - Flexible Spending Account (FSA) - 401k + Company Match - Life, AD&D, Short Term and Long-Term Disability Insurance - Bonus Plan Eligibility - Employee Equity Program - Paid Holidays & Vacation - Employee Assistance Program - Inclusive Team Environment These evergreen postings are designed to connect us with talented individuals interested in future opportunities at Anteris Technologies. Because openings may vary over time, additional details regarding specific responsibilities, qualifications, work arrangements, and compensation will be shared as candidates move forward in the process for individual roles. 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.*