Principal Clinical Safety Specialist

Anteris Tech

6d•$140 - $170•Remote

About The Position

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 an experienced Safety Specialist to lead and execute global safety activities across clinical development and post-market phases of our structural heart programs. This role is critical to ensuring patient safety, regulatory compliance, and the integrity of our global pivotal trial and commercialization strategy. The ideal candidate brings hands-on experience in Class III implantable cardiovascular devices, ideally transcatheter aortic valve replacement (TAVR), and thrives in a fast-paced, cross-functional environment. 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.

Requirements

Bachelor’s degree in Nursing, Life Sciences, Biomedical Engineering, Pharmacy, or related field required; advanced degree (MS, PharmD, MD, PhD, RN, NP) strongly desired.
Minimum 5–8 years of medical device safety experience with direct experience with Class III implantable cardiovascular devices.
Demonstrated hands-on experience with:
Global clinical trial safety reporting
FDA IDE and PMA safety submissions
EU MDR vigilance requirements
CEC and DSMB oversight
Strong understanding of regulatory safety reporting requirements such as:
21 CFR 803, 812
EU MDR 2017/745 vigilance requirements
ISO 14155
ICH GCP
Experience integrating complaint handling with clinical safety data.
Proven ability to work cross-functionally with Regulatory Affairs, Clinical Operations, Clinical Science, Quality, and Engineering teams.

Nice To Haves

Experience in TAVR, cardiovascular transcatheter therapies or other structural heart experience.
Experience in both clinical development and post-market safety environments.
Experience in small or growing medical device companies.

Responsibilities

Lead safety monitoring activities across global clinical trials, including pivotal and post-approval studies.
Collaboration with CRO partners in the creation and execution of study-specific Safety Management Plans (SMPs) and safety charters.
Serve as primary safety liaison for Clinical Events Committees (CEC), DSMB/DMC, and Independent Medical Monitors
Ensure timely and compliant reporting of AEs, SAEs, UADEs, and device deficiencies in accordance with FDA, EU MDR, and other global regulatory requirements.
Partner closely with Regulatory Affairs to prepare safety reports to health authorities worldwide.
Collaboration with clinical operations to reconcile safety events between EDC, safety databases, and complaint systems.
Author safety sections of trial protocols and collaborates with clinical operations to train external clinical research teams to the defined safety process
Monitors data to assure compliance with the documented safety
Work in close partnership with Regulatory Affairs to interpret global vigilance requirements and ensure accurate, consistent submissions.
Support creation of safety summaries for annual reports, EU vigilance reporting, and global regulatory submissions.
Provide safety input into regulatory strategy discussions and risk assessments.
Act as clinical representative in cross functional risk management, complaints, and CAPA teams.
Oversee and execute global adverse event and device deficiency reporting process.
medical review, coding, seriousness and causality assessments.
Creation of safety trending and signal detection processes.
Ensure consistency between clinical safety reporting and post-market vigilance activities.
Perform ongoing signal detection and trend analysis across clinical and post-market data sources.
Lead benefit-risk assessments and support Health Risk Assessments (HRA) when required.
Clinical harms library ownership and contribution to risk management processes (e.g. RMPs, FMEAs, hazard analyses).
Escalate emerging safety issues proactively and provide clear medical rationale for decision-making.
Support global vigilance reporting under FDA MDR and EU MDR frameworks.
Contribute to PSURs and post-market clinical follow-up activities.
Partner with Quality to integrate field feedback and complaint trends into continuous improvement efforts.

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 & Vacation
Employee Assistance Program
Inclusive Team Environment