Anteris Technologies
Overview
Join to apply for the
Principal Medical Safety Specialist
role at
Anteris Technologies . 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. 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 are pursuing the world’s first biomimetic TAVR valve, DurAVR® THV, incorporating our proprietary 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. This role collaborates with cross‑functional teams to mitigate risks, address safety concerns, and drive post‑market surveillance activities. You will be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices.
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.
Issue and resolve safety queries within EDC systems; reconcile events with QA/Complaints systems.
Manage or oversee 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 with Regulatory Affairs and Clinical Operations.
Review safety-related sections of clinical study reports, statistical outputs, and informed consent forms for accuracy, clarity, and regulatory compliance.
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 PMS activities, including vigilance reporting and trend analysis; investigate potential safety signals and escalate issues as appropriate; collaborate with QA to integrate field feedback into product improvement initiatives.
Clinical & Regulatory Collaboration: Serve as a medical safety liaison with investigators, clinicians, and study sites; respond to safety-related clinical inquiries and provide training/support; stay current with evolving global safety regulations and standards (FDA, EU MDR, ISO 14155, ISO 13485, ICH GCP).
Documentation & Data Management: Maintain accurate, complete, and confidential safety case records; manage and utilize safety databases for high-quality data entry, tracking, and reporting.
Qualifications
Bachelor’s degree in Nursing, Pharmacy, Life Sciences, Biomedical Engineering, or related discipline required; advanced degree or 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 to detect, assess, and escalate safety signals; excellent verbal and written communication; 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.
Additional Information
This role may be filled at varying levels (e.g., Specialist or Manager) depending on the candidate's experience.
Reports to the SVP of Clinical & Regulatory Affairs.
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; FSA; 401k + company match; Life, AD&D, Short/Long-Term Disability; Bonus Plan Eligibility; Employee Equity; Paid Holidays & PTO; EAP; 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 strive to be a place of belonging for all humans by promoting diversity, multiculturalism and inclusion. Diversity is part of our mission to deliver the best structural heart products on a global scale.
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Join to apply for the
Principal Medical Safety Specialist
role at
Anteris Technologies . 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. 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 are pursuing the world’s first biomimetic TAVR valve, DurAVR® THV, incorporating our proprietary 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. This role collaborates with cross‑functional teams to mitigate risks, address safety concerns, and drive post‑market surveillance activities. You will be part of a team dedicated to enhancing the quality of life for patients with aortic stenosis through groundbreaking medical devices.
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.
Issue and resolve safety queries within EDC systems; reconcile events with QA/Complaints systems.
Manage or oversee 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 with Regulatory Affairs and Clinical Operations.
Review safety-related sections of clinical study reports, statistical outputs, and informed consent forms for accuracy, clarity, and regulatory compliance.
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 PMS activities, including vigilance reporting and trend analysis; investigate potential safety signals and escalate issues as appropriate; collaborate with QA to integrate field feedback into product improvement initiatives.
Clinical & Regulatory Collaboration: Serve as a medical safety liaison with investigators, clinicians, and study sites; respond to safety-related clinical inquiries and provide training/support; stay current with evolving global safety regulations and standards (FDA, EU MDR, ISO 14155, ISO 13485, ICH GCP).
Documentation & Data Management: Maintain accurate, complete, and confidential safety case records; manage and utilize safety databases for high-quality data entry, tracking, and reporting.
Qualifications
Bachelor’s degree in Nursing, Pharmacy, Life Sciences, Biomedical Engineering, or related discipline required; advanced degree or 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 to detect, assess, and escalate safety signals; excellent verbal and written communication; 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.
Additional Information
This role may be filled at varying levels (e.g., Specialist or Manager) depending on the candidate's experience.
Reports to the SVP of Clinical & Regulatory Affairs.
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; FSA; 401k + company match; Life, AD&D, Short/Long-Term Disability; Bonus Plan Eligibility; Employee Equity; Paid Holidays & PTO; EAP; 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 strive to be a place of belonging for all humans by promoting diversity, multiculturalism and inclusion. Diversity is part of our mission to deliver the best structural heart products on a global scale.
#J-18808-Ljbffr