Director - Post Market Quality

Location: Austin, Texas, United States; hybrid

Base salary estimate: $180,000–$225,000 per year for the San Francisco Bay Area, plus cash bonus and equity.

Company

hirify.global is a publicly traded medical technology company developing AI-driven, non-invasive cardiac diagnostics for coronary artery disease.

What you will do

• Lead complaint handling, product investigations, and the designated Complaint Handling Unit.
• Own FDA MDR, EU vigilance, and PMDA adverse event reporting, including reportability decisions and submission timelines.
• Direct field actions, recalls, corrections and removals, and post-market health hazard evaluations.
• Own the EU MDR post-market surveillance system, including PMS plans, PMS reports, PSURs, and PMCF activities.
• Establish proactive trending, signal detection, and real-world performance monitoring for AI/ML-enabled medical device functions.
• Lead and develop complaint, investigation, and engineering teams while partnering with Regulatory Affairs, Clinical, R&D, Customer Support, and Commercial.

Requirements

• Bachelor’s degree in engineering, a scientific discipline, or equivalent experience.
• 13+ years of progressive Quality experience in the medical device industry, including 7+ years in leadership or management.
• Expert knowledge of 21 CFR Parts 803, 806, and 820, EU MDR, ISO 13485, and ISO 14971.
• Demonstrated ownership of MDR and vigilance reporting decisions and experience with FDA, Notified Body, or MDSAP inspections.
• Deep expertise in complaint handling, post-market surveillance, field actions, and regulated medical device quality systems.
• Working understanding of Software as a Medical Device, ideally involving AI-based products.

Nice to have

• Experience with AI/ML-driven SaMD and cloud-based medical device platforms.
• Experience monitoring algorithm drift, accuracy, and subgroup performance in real-world use.
• Experience authoring and defending PSURs and PMS reports during Notified Body audits.
• Experience modernizing and scaling complaint handling and post-market processes.

Culture & Benefits

• Quality-first and patient-centric decision-making culture.
• High-visibility collaboration with leadership and executive management.
• Responsibility for departmental resources, headcount planning, budget, and strategic planning.
• Hybrid work arrangement with cash bonus and equity compensation.
• Equal opportunity work environment supporting and respecting all individuals.