Director, Clinical Quality & Compliance (MedTech)

Location: San Francisco, California; hybrid work

Salary: $215,000–$270,000 base salary, plus cash bonus and equity.

Company

hirify.global is a publicly traded medical technology company developing AI-driven, non-invasive solutions for the diagnosis and management of coronary artery disease.

What you will do

• Lead clinical quality and regulatory compliance strategies across pre-market and post-market clinical programs.
• Oversee compliance with FDA Good Clinical Practice, FDA IDE requirements, ISO 14155, and medical device labeling standards.
• Prepare for and lead BIMO audits, internal GCP audits, vendor oversight, and regulatory health authority inspections.
• Establish monitoring protocols and oversee ICFs, Investigator’s Brochures, site oversight plans, Trial Master File standards, and regulatory document packages.
• Manage oversight of protocol deviations, root-cause analysis, CAPA, UADE and SAE reporting workflows.
• Partner with Clinical Operations, Regulatory Affairs, CROs, and clinical vendors on global trials, PMCF studies, CERs, literature searches, and PSURs.

Requirements

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Clinical Research, or a related scientific or health field.
• At least 8 years of relevant experience in clinical quality assurance and regulatory affairs within medical device, biotech, or combination product industries.
• Deep knowledge of FDA IDE regulations, FDA GCP standards, ISO 14155, and medical device labeling requirements.
• Hands-on experience with BIMO audit readiness, FDA IDE submissions, regulatory inspections, ICFs, IBs, IFUs, PMCF plans, and PSURs.
• Experience managing CROs and clinical vendors, protocol deviations, CAPA systems, and UADE/SAE safety reporting.
• Excellent written and oral English communication skills required.

Nice to have

• Master’s degree, Ph.D., PharmD, or RN qualification.
• Demonstrated experience leading BIMO audit readiness and FDA IDE submissions.

Culture & Benefits

• Hybrid work environment in San Francisco.
• Cash bonus and equity in addition to base salary.
• Collaborative, cross-functional work with Clinical Operations, Regulatory Affairs, CROs, and clinical vendors.
• Equal opportunity work environment focused on respect and inclusion.