Heartflow · 1 day ago
Senior Post-Market Surveillance Specialist
San Francisco Bay Area, California, United States
Full-time
Onsite
Senior Level, Lead/Staff
$85K/yr - $115K/yr
8+ years expHeartflow is a medical technology company advancing the diagnosis and management of coronary artery disease. As a Senior Post-Market Surveillance Specialist, you will ensure the safety and regulatory integrity of products post-market, develop and maintain PMS processes, and analyze data to identify trends for continuous product improvement.
Artificial Intelligence (AI)BiotechnologyHealth CareHealth DiagnosticsMedical
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 Health Hazard Evaluations (HHE) and hazard mitigation, while assisting in the implementation of CAPA and Nonconformance Reports (NCR)
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
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
Qualification
Required
Experience in the medical device industry with a clear understanding of product complaint handling processes, trending, and regulatory reporting procedures
Creation and maintenance of post-market surveillance plans and reports to ensure continuous compliance and product safety throughout the product lifecycle
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
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 Health Hazard Evaluations (HHE) and hazard mitigation, while assisting in the implementation of CAPA and Nonconformance Reports (NCR)
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
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
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
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
Preferred
Experience with software medical device products (class II/III) preferred
Company
Heartflow
Heartflow is a medical technology company that provides various methods of diagnosis and treatment of cardiovascular disease.
501-1000 employees
H1B Sponsorship
Heartflow has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (3)
2023 (6)
2022 (9)
2021 (12)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$890.72MKey Investors
Bain Capital Life SciencesPanorama Point PartnersCapricorn Investment Group
2025-08-08IPO
2025-03-26Convertible Note· $98M
2023-04-06Series F· $215M
Leadership Team
John Farquhar
President and CEO
Campbell Rogers
Chief Medical Officer
Recent News
The Motley Fool
2025-12-19
Company data provided by crunchbase