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.

• 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.
  • Issue and resolve safety queries within EDC systems; reconcile events with Quality Assurance/Complaints systems.
  • Manage or oversee activities of safety committees (CEC, DSMB/DMC, Independent Medical Monitor) in alignment with study charters.
  • Ensure timely and compliant safety reporting of AEs, SAEs, UADEs, and SUSARs in collaboration with Regulatory Affairs and Clinical Operations.
  • Review safety-related sections of clinical study reports, statistical outputs, and informed consent forms to ensure accuracy, clarity, and compliance with regulations.
  • Support SOP development, process improvements, and implementation of best practices in medical safety.
• Risk Management
  • Partner with Clinical, R&D, and Engineering teams to identify and assess potential device risks.
  • Conduct risk-benefit evaluations and contribute to ongoing device risk management activities.
• Post-Market Surveillance
  • Lead or support post-market surveillance (PMS) activities, including vigilance reporting and trend analysis.
  • Investigate potential safety signals and escalate issues as appropriate.
  • Collaborate with Quality Assurance to integrate field feedback into product improvement initiatives.
• Clinical & Regulatory Collaboration
  • Serve as a medical safety liaison with investigators, clinicians, and study sites to ensure proper communication of device safety information.
  • Respond to safety-related clinical inquiries and provide training/support where needed.
  • Stay current with evolving global safety regulations, guidance, and standards; ensure compliance with FDA, EU MDR, ISO 14155, and other relevant frameworks.
• Documentation & Data Management
  • Maintain accurate, complete, and confidential safety case records and documentation.
  • Manage and utilize safety databases to ensure high-quality data entry, tracking, and reporting.

• Bachelor’s degree in Nursing, Pharmacy, Life Sciences, Biomedical Engineering, or related discipline required; advanced degree / medical background strongly preferred.
• Minimum of 5 years’ experience in medical device safety, pharmacovigilance, or clinical safety monitoring (Class III implantable devices required).
• Demonstrated experience managing safety processes for clinical trials, including CEC and DSMB / DMC operations.
• Solid understanding of…