Senior Medical Devices Safety Specialist

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.

We are seeking a Medical Safety Specialist to play a crucial role in monitoring, assessing, and ensuring the safety of our biomimetic TAVR valve throughout its lifecycle. The Clinical Safety Specialist role will collaborate with multidisciplinary teams to mitigate risks, address safety concerns, and contribute to post-market surveillance efforts.

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.

This role may be filled at varying levels, e.g., Sr Specialist or Manager, depending on the candidate's previous experience, and will report to the VP of Clinical and Regulatory.

KEY RESPONSIBILITIES

Safety Monitoring and Reporting:

• Continuously monitor, collect, and review adverse event reports, malfunctions, and other safety-related data for the biomimetic TAVR valve.
• Prepare and submit timely, accurate safety reports to regulatory bodies in accordance with global regulations.

Management of Clinical Trial Safety-related Processes:

• Develop, implement and manage study-specific Safety Management Plan (SMP) and Case Report Forms (e.g., AE, DD/DM, and Adjudication CRFs) and associated Charters
• Review draft informed consent forms (both templates and site-specific), ensure they include all required elements, are written in plain language, and are tailored to the specific study and participant population, while also adhering to relevant regulations and guidelines.
• Safety requests for, and review of, source documents
• Issue and resolve safety queries in the study database
• Event reconciliation between EDC and Quality Assurance/Complaints
• Manage activities related to study committees (CEC, DSMB/DMC, Independent Medical Monitor) or oversee third party management of committee activities per study SMP and associated Charters
• Manage accurate and timely safety related regulatory reporting (AEs, SAEs, UADEs) per study and regulatory requirements, including collaboration with regulatory affairs and clinical operations, or overseeing activities of third-party managing safety reporting.
• Review applicable study reports and statistical outputs as needed
• Support the review, implementation, and execution of standard operating procedures (SOPs)
• Contribute to the development and implementation of medical safety program initiatives, process improvements and sound safety practices
• Other clinical trial safety activities as directed

Risk Assessment:

• Collaborate with the clinical and engineering teams to identify potential risks associated with the device.
• Develop risk assessment strategies and conduct risk-benefit analyses for the biomimetic TAVR valve.

Post-Market Surveillance:

• Lead post-market surveillance activities, ensuring prompt identification and investigation of any potential safety concerns.
• Collaborate with Quality Assurance to ensure feedback from the field is integrated into the device's continuous improvement process.

Clinical Collaboration:

• Act as a safety liaison between the company and clinicians, ensuring they are adequately informed about the safe and effective use of the device.
• Address clinical inquiries related to device safety and provide training when necessary.

Regulatory Compliance:

• Stay up to date with local, national, and international regulations and standards related to medical device safety.
• Collaborate with the Regulatory Affairs team to ensure compliance with safety-related regulatory requirements.

Documentation and Data Management:

• Maintain meticulous records of all safety data, investigations, and reports.
• Implement and oversee the use of safety databases, ensuring data integrity and confidentiality.

Skills, Knowledge, Experience, Qualifications

• Bachelor's degree in a relevant field (e.g., Nursing, Healthcare and Lifesciences, Biomedical Engineering, Pharmacy) required. Advanced degree preferred.
• Minimum of 5 years’ experience in medical device safety.
• Requires a minimum of 5 years’ experience implementing safety processes in medical device clinical trials
• Experience managing and executing processes for CEC and DSMB/DMC
• Knowledge of global medical device regulations and standards (e.g., FDA, EU MDR, ISO 13485).
• Excellent analytical and problem-solving skills.
• Strong written and verbal communication abilities.
• Ability to work in a fast-paced environment and manage multiple priorities.

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 Offerings
• Flexible Spending Account (FSA)
• 401k + Company Match
• Life, AD&D, Short Term and Long-Term Disability Insurance
• Bonus Plan Eligibility
• Employee Stock Option Plan
• Paid Holidays & Vacation
• Employee Assistance Program
• Inclusive Team Environment

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.