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Senior Post-Market Surveillance Specialist

San Francisco Bay Area, California, United States

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.  

The Opportunity

As our 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.

The Senior Post-Market Surveillance Specialist requires experience in the medical device industry with a clear understanding of product complaint handling processes, trending, and regulatory reporting procedures. This role is responsible for the creation and maintenance of post-market surveillance plans and reports to ensure continuous compliance and product safety throughout the product lifecycle. This role is responsible for developing, implementing, and maintaining post-market surveillance (PMS) processes to ensure compliance with global regulatory requirements, including but not limited to FDA (21 CFR 820, 803, 806) and EU MDR.

Job Responsibilities:

  • PMS Development & Maintenance: Maintain accurate PMS processes and procedures, including PMS Plans, Reports, and Periodic Safety Update Reports (PSUR), in compliance with international regulations and industry standards.
  • Regulatory Reporting: Ensure timely and accurate Medical Device Reporting (MDR) and adverse event reporting to external regulatory authorities as required.
  • Data Analysis & Statistical Trending: Collect, evaluate, and analyze investigation data using systems such as Jira, Salesforce and Tableau to identify trends, potential risks, and opportunities for product improvement.
  • Proactive Surveillance: Conduct proactive PMS activities, including web screening, MAUDE searches, and review customer surveys, to identify emerging issues.
  • Field Actions & Recalls: Coordinate product field action activities, including identification, risk assessment, stakeholder communication, and coordination of corrective actions.
  • Risk Management & CAPA: Participate in risk management activities, including Health Hazard Evaluations (HHE) and hazard mitigation, while assisting in the implementation of CAPA and Nonconformance Reports (NCR).
  • Strategic Leadership & Optimization: Provide training, guidance, and mentorship to team members and cross-functional stakeholders while identifying and implementing improvements in PMS processes, SOPs, and work instructions to enhance overall compliance and efficiency.
  • Cross-Functional Influence: 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.
  • Process Optimization: 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: 

  • Education: Bachelor’s degree in Science, Engineering,  or a related field.
  • Experience: 8+ years of relevant experience in the medical device industry, software medical device products (class II/III) preferred.

This position has an estimated base salary of $85,000-$115,000 (for San Francisco Bay Area) and bonus. #LI-IB1

Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals 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.
 
Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.
 
Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify the following: A) all legitimate Heartflow recruiter email addresses end with “@heartflow.com” and B) the position described is found on our careers site at www.heartflow.com/about/careers/. 

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