Principal Medical Safety Specialist

Anteris Technologies Global-posted 2 months ago
Senior
Eagan, MN
101-250 employees
Miscellaneous Manufacturing
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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 Principal Medical Safety Specialist to play a critical role in monitoring, assessing, and ensuring the safety of our biomimetic TAVR valve throughout its lifecycle. This position will collaborate 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.

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 global regulations and standards: FDA (21 CFR), EU MDR, ISO 13485, ISO 14155, ICH GCP.
  • Strong analytical skills with ability to detect, assess, and escalate safety signals.
  • Excellent verbal and written communication skills; proven ability to draft regulatory-quality documents.
  • Ability to manage multiple priorities in a fast-paced environment with attention to detail and compliance.
  • Strong cross-functional collaboration and stakeholder management skills.
  • 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
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