Senior Post-Market Surveillance Specialist
Heartflow, San Francisco, California, United States, 94199
About Heartflow
Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap Analysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.
Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 500,000 patients worldwide.
Opportunity As a Senior Post-Market Surveillance Specialist, you will contribute to our product’s safety and regulatory integrity after it reaches the hands of clinicians and patients. This isn’t just a compliance role; you will be a strategic bridge between real-world data and engineering. You will architect and maintain our PMS frameworks to ensure global compliance while leveraging data to drive continuous product improvement.
Job Responsibilities
Maintain accurate PMS processes and procedures, including PMS Plans, Reports, and Periodic Safety Update Reports (PSUR), in compliance with international regulations and industry standards.
Ensure timely and accurate Medical Device Reporting (MDR) and adverse event reporting to external regulatory authorities as required.
Collect, evaluate, and analyze investigation data using systems such as Jira, Salesforce, and Tableau to identify trends, potential risks, and opportunities for product improvement.
Conduct proactive PMS activities, including web screening, MAUDE searches, and review customer surveys, to identify emerging issues.
Coordinate product field action activities, including identification, risk assessment, stakeholder communication, and coordination of corrective actions.
Participate in risk management activities, including (H hazard, while assisting in the implementation of CAPA and Nonconformance Reports (NCR).
Provide training, guidance, and mentorship team members and cross‑functional stakeholders while identifying and implementing improvements in PMS processes, SOPs, and work instructions to enhance overall compliance and efficiency.
Serve as a subject matter expert on post‑market data for R&D, Clinical, and Marketing teams to ensure product efficacy and safety throughout the lifecycle.
Identify efficiencies in our surveillance workflows to scale our operations.
Skills Needed
Regulatory Knowledge and deep understanding of 21 CFR 820.198, 21 CFR 803, 21 CFR 806, MEDDEV Annex 3 / Annex 4, EU MDR, Health Canada MPR, ISO13485, and ISO 14971.
Proficient with Salesforce, Tableau, Electronic Document Management Systems (EDMS), Google Workspace, and MS Office.
Strong critical thinking skills and great attention to detail.
Ability to work as a self‑starter in a fast‑paced, adaptive environment.
Excellent communication, documentation, and time management skills.
Ability to stay current with global regulatory requirements and industry best practices.
Educational Requirements & Work Experience
Bachelor’s degree in Science Engineering, or a related field.
8+ years of relevant experience in the medical device industry, software medical device products (class II/III) preferred.
Compensation & Benefits This position has an estimated base salary of $85,000-$115,000 (for San Francisco Bay Area) or $75,000 to $95,000 (for all locations outside of San Francisco Bay Area), and bonus.
Equal Opportunity Employer Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.
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Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 500,000 patients worldwide.
Opportunity As a Senior Post-Market Surveillance Specialist, you will contribute to our product’s safety and regulatory integrity after it reaches the hands of clinicians and patients. This isn’t just a compliance role; you will be a strategic bridge between real-world data and engineering. You will architect and maintain our PMS frameworks to ensure global compliance while leveraging data to drive continuous product improvement.
Job Responsibilities
Maintain accurate PMS processes and procedures, including PMS Plans, Reports, and Periodic Safety Update Reports (PSUR), in compliance with international regulations and industry standards.
Ensure timely and accurate Medical Device Reporting (MDR) and adverse event reporting to external regulatory authorities as required.
Collect, evaluate, and analyze investigation data using systems such as Jira, Salesforce, and Tableau to identify trends, potential risks, and opportunities for product improvement.
Conduct proactive PMS activities, including web screening, MAUDE searches, and review customer surveys, to identify emerging issues.
Coordinate product field action activities, including identification, risk assessment, stakeholder communication, and coordination of corrective actions.
Participate in risk management activities, including (H hazard, while assisting in the implementation of CAPA and Nonconformance Reports (NCR).
Provide training, guidance, and mentorship team members and cross‑functional stakeholders while identifying and implementing improvements in PMS processes, SOPs, and work instructions to enhance overall compliance and efficiency.
Serve as a subject matter expert on post‑market data for R&D, Clinical, and Marketing teams to ensure product efficacy and safety throughout the lifecycle.
Identify efficiencies in our surveillance workflows to scale our operations.
Skills Needed
Regulatory Knowledge and deep understanding of 21 CFR 820.198, 21 CFR 803, 21 CFR 806, MEDDEV Annex 3 / Annex 4, EU MDR, Health Canada MPR, ISO13485, and ISO 14971.
Proficient with Salesforce, Tableau, Electronic Document Management Systems (EDMS), Google Workspace, and MS Office.
Strong critical thinking skills and great attention to detail.
Ability to work as a self‑starter in a fast‑paced, adaptive environment.
Excellent communication, documentation, and time management skills.
Ability to stay current with global regulatory requirements and industry best practices.
Educational Requirements & Work Experience
Bachelor’s degree in Science Engineering, or a related field.
8+ years of relevant experience in the medical device industry, software medical device products (class II/III) preferred.
Compensation & Benefits This position has an estimated base salary of $85,000-$115,000 (for San Francisco Bay Area) or $75,000 to $95,000 (for all locations outside of San Francisco Bay Area), and bonus.
Equal Opportunity Employer Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.
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