Clinical and Regulatory Affairs

🕒 5 days ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Anteris Technologies

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2006

🏥 Healthcare

🔧 Hardware

Healthcare • Hardware

Anteris Technologies is a medical technology company focused on developing next-generation transcatheter heart valve solutions to treat aortic stenosis. The company’s lead product, the DurAVR® Transcatheter Heart Valve (THV), is a single-piece, native-shaped biomimetic valve designed to mimic healthy aortic valve physiology and restore laminar flow. Anteris emphasizes science-driven, measurable improvements in cardiac outcomes, citing early clinical and retrospective analyses (EMBARK, EFS, PARADIGM and investigator-led studies) reporting favorable hemodynamics, reduced patient-prosthesis mismatch, and promising short-term safety signals. DurAVR® is currently available for investigational use only while the company pursues regulatory approvals and broader clinical evaluation. Anteris also engages with the medical community through presentations, webinars, and investigator-sponsored research to build clinical evidence for its biomimetic TAVR approach.

📋 Description

• 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.

🎯 Requirements

• Clinical operations • Clinical monitoring • Physician support • Field clinical education • Global regulatory compliance, or • Clinical trial management within the medical device industry.

🏖️ 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. • Career development opportunities and a chance to be part of a growing company that values its employees. • 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