Principal Medical Safety Specialist

Overview

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. We seek to restore healthy blood flow patterns by creating the world's first biomimetic TAVR valve, DurAVR THV, designed to mimic the natural function of a healthy heart valve with our ADAPT anti-calcification technology.

We are seeking a

Principal Medical Safety Specialist

to monitor, assess, and ensure the safety of our biomimetic TAVR valve throughout its lifecycle, collaborating with cross-functional teams to mitigate risks, address safety concerns, and drive post-market surveillance activities.

At Anteris Technologies, you'll be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices. Join us in our mission to revolutionize structural heart solutions.

Responsibilities

Safety Monitoring & Reporting

Collect, monitor, and analyze adverse events, device deficiencies, malfunctions, and safety-related data.

• Request and review source documentation to support case assessments.
• Determine event reportability in accordance with FDA, EU MDR, and other applicable regulations.
• Generate case narratives for event adjudication, study reports, and regulatory submissions.
• Prepare and submit timely, accurate safety reports to global health authorities.
• Conduct literature reviews and contribute to periodic safety update reports (PSURs), annual safety reports, and risk management updates.

Clinical Trial Safety Management

Develop and implement study-specific Safety Management Plans (SMPs), safety case report forms, and related charters.

Risk Management

Partner with Clinical, R&D, and Engineering teams to identify and assess potential device risks.

Post-Market Surveillance

Lead or support post-market surveillance (PMS) activities, including vigilance reporting and trend analysis.

Clinical & Regulatory Collaboration

Serve as a medical safety liaison with investigators, clinicians, and study sites to ensure proper communication of device safety information.

Documentation & Data Management

Maintain accurate, complete, and confidential safety case records and documentation.

Qualifications

Additional Information

What We Offer

Health and Wellness Offerings

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, multiculturalism 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.

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