Principal Medical Safety Specialist
Anteris TechnologiesHighlight
Summary
About the Role
About You
- Bachelor’s degree in Nursing, Pharmacy, Life Sciences, Biomedical Engineering, or related discipline required.
- Minimum of 5 years’ experience in medical device safety, pharmacovigilance, or clinical safety monitoring (Class III implantable devices required).
- Solid understanding of global regulations and standards: FDA (21 CFR), EU MDR, ISO 13485, ISO 14155, ICH GCP.
- Advanced degree / medical background strongly preferred.
- Demonstrated experience managing safety processes for clinical trials, including CEC and DSMB / DMC operations.
- Strong analytical skills with ability to detect, assess, and escalate safety signals.
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 Offerings.
- 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 & PTO.
- Employee Assistance Program.
- Inclusive Team Environment.
Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. 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 sought 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.