# Staff Regulatory Affairs Engineer
**Company:** [Hinge Health](https://hotfix.jobs/companies/hinge-health)
**Location:** San Francisco, CA
**Salary:** $168K-$252K
**Experience:** 7+ years
**Skills:** Fda 510(K), De Novo, Predetermined Change Control Plans, Pccp, Ai/Ml Samd, Iec 62304, Iso 13485, 21 Cfr 820, Good Machine Learning Practice, Gmlp, Quality Management System, Qms, Software Validation
**Posted:** 2026-04-08
> Leads regulatory strategy, authorship, and submissions (510(k), De Novo) for AI/ML Software as a Medical Device. Partners with Product, Clinical, and Engineering teams to ensure FDA compliance and QMS maintenance. Requires 7+ years in med device regulatory affairs with SaMD focus and bachelor's degree.
## Job Description
## Responsibilities

- Lead the planning, authorship, and submission of regulatory filings (510(k), De Novo, Q-Submissions) for AI/ML-enabled software.
- Develop and execute regulatory strategies for new product introductions and major software updates.
- Participate in Design Reviews and Change Control Boards to assess regulatory impact of software changes, evaluating AI models and retraining pipelines.
- Support maintenance of Quality Management System (QMS) ensuring compliance with 21 CFR 820 and ISO 13485.
- Review and approve labeling, marketing materials, and user manuals.
- Monitor post-market performance of AI models and lead assessments for regulatory reporting (eMDRs).
- Educate cross-functional teams on regulatory principles.

## Basic Qualifications

- **Education**: Bachelor’s degree in Biomedical Engineering, Software Engineering, Regulatory Science, or related field.
- **Experience**: 7+ years in Regulatory Affairs in medical device industry, with 3+ years in SaMD or Digital Health.
- Proven track record of authoring and clearing US FDA Class II submissions (510(k) or De Novo).
- Experience interfacing with FDA reviewers.
- Technical fluency in software architecture, cloud infrastructure, AI/ML concepts; familiarity with IEC 62304 and FDA Software Validation Guidance.

## Preferred Qualifications

- Direct experience with regulatory submissions involving Machine Learning, Deep Learning, or Computer Vision.
- Familiarity with Good Machine Learning Practice (GMLP) and Predetermined Change Control Plans (PCCP).
- Experience with international registrations (EU MDR, Health Canada).
- Ability to review statistical analysis plans and clinical validation reports.
- Experience in Agile/Scrum environments.
**Apply:** https://hotfix.jobs/jobs/staff-regulatory-affairs-engineer-at-hinge-health-97b613bc-c163-4c45-a6ac-40a48cf9f118
**Canonical:** https://hotfix.jobs/jobs/staff-regulatory-affairs-engineer-at-hinge-health-97b613bc-c163-4c45-a6ac-40a48cf9f118