Director - Post Market Quality
HeartflowMedical Diagnostics company
Austin, United States$180,000 to $225,000 per yearDirector
Baillie Gifford
Bain Capital Life Sciences
Fidelity
Janus Henderson
USVP
Capricorn
Operations & Strategy
About the role
TL;DR
Director of Post-Market Quality to manage product performance systems and regulatory obligations.
- •Heartflow is seeking a Director of Post-Market Quality to oversee systems that track product performance in the field and manage regulatory obligations.
- •This role leads the Designated Complaint Handling Unit, Product Investigations team, global adverse event reporting, field actions, and post-market surveillance processes.
- •Key Responsibilities Lead complaint handling, product investigations, and adverse event reporting.
- •Own reportability decision-making and timely submission of regulatory reports.
- •Manage field actions, recalls, and health hazard evaluations.
- •Oversee EU MDR post-market surveillance systems, including PMS plans and reports.
- •Provide strategic leadership, governance, and team development for the post-market quality function.
- •Requirements Expert-level knowledge of medical device regulations (21 CFR Parts 820, 803, 806, EU MDR, ISO 13485, ISO 14971). 13+ years of progressive quality experience in the medical device industry, with 7+ years in leadership.
- •Experience with Software as a Medical Device (SaMD), ideally AI-based.
- •Proven track record in regulatory inspections and audits.
- •Strong communication, regulatory judgment, and integrity.
Required skills
Risk ManagementCompliance ManagementProduct Management
Domain expertise
healthtech
Benefits & perks
cash bonus, equity