Senior Post-Market Surveillance Specialist

Heartflow • San Francisco, CA

5d • $85,000 - $115,000

About The Position

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.

Requirements

• 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
• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees