What are the responsibilities and job description for the Director, Regulatory & Quality position at Clairity, Inc.?
Location: Boston, MA
Company Overview
We are a healthcare technology company with validated science, real-world impact, and strong momentum. As we scale that impact, we are building the team and systems to ensure rapid, high-quality execution within a regulated environment.
Where You Fit
Reporting to the CEO, you will own regulatory strategy, FDA engagement, and companywide quality systems. You will work together with engineering and software teams to shape how our FDA-regulated products are designed, built, and maintained. This means influencing product decisions from the start, defining what’s in scope for a submission, how changes are managed, and what documentation and controls are required throughout the software lifecycle. You will be the internal authority on what it takes to ship compliant, high-quality software in a regulated environment.
This role is ideal for someone who wants direct influence over product direction, not just reviewing what engineering builds, but partnering with them to decide what we build and how.
What You’ll Do
- Own end-to-end regulatory strategy for our SaMD platform, including future 510(k) submissions and international filings
- Serve as the primary point of contact with FDA and other regulatory bodies
- Lead and maintain the Quality Management System (QMS) in compliance with FDA, ISO 13485 and other related standards
- Partner with engineering to ensure design controls, software lifecycle documentation, and validation processes meet regulatory requirements
- Manage CAPA, nonconformance investigations, and complaint handling processes
- Oversee internal and external audits, always ensuring audit readiness
- Establish and maintain SOPs, document control, and quality records
- Prepare risk assessments and communicate regulatory risks to leadership
- Monitor regulatory landscape and update policies and procedures as requirements evolve
- Support clinical site deployments and customer quality inquiries
What You Bring
Required
- 10 years of experience in regulatory affairs and/or quality within medical devices, digital health, or SaMD
- Direct experience leading FDA 510(k) or De Novo submissions for software or AI/ML-based devices
- Hands-on experience building or maintaining a QMS under ISO 13485 and FDA regulations
- Strong understanding of design controls, risk management (ISO 14971), and software validation
- Proven ability to translate complex regulatory requirements into clear guidance for engineering and product teams
- Experience managing CAPA, nonconformance, and audit processes
- Excellent written and verbal communication skills
- High ownership, strong follow-through, and sound judgment
- Comfortable operating as a lean team; resourceful and self-directed
Nice to Have
- Experience with international regulatory pathways (CE marking, EU MDR, Health Canada)
- Background in AI/ML regulatory considerations and predetermined change control plans
- RAC certification or advanced degree in a relevant field
- Experience in radiology, breast imaging, or oncology-related devices
- Prior experience at an early-stage or high-growth company
Compensation and Growth
- Base salary: $180,000 – $210,000 (commensurate with experience and capability)
- Performance-based bonus
- Generous health benefits and 401(k) contribution
- Significant opportunity for expanded responsibility, scope, and long-term participation in the company’s growth
About Clairity
Clairity is a healthcare technology company redefining how disease risk is understood and managed.
We leverage advances in AI and computer vision to transform how medical images are used, moving beyond the detection of visible disease toward the prediction of future risk and the enablement of earlier, more proactive care.
In a short period of time, we moved from research to model development, FDA de novo regulatory authorization, inclusion in national clinical guidelines, and real-world implementation at leading centers of excellence, including Beth Israel Deaconess Medical Center, Emory University, and Invision Sally Jobe, demonstrating strong momentum and real-world impact.
We are shifting healthcare from reactive diagnosis to proactive risk assessment, disease prevention, and health promotion.
We operate with a high bar for excellence in speed and quality. We are execution-driven, operate with ownership, and move quickly with judgment.
To apply, please send your resume to corporatejobs@clairity.com
Salary : $180,000 - $210,000