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Senior Regulatory Affairs Program Manager

Hinge HealthSan Francisco-HQRnD
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Salary
$168K – $225K
Job type
Full-time
Work mode
Remote
Posted
8 Apr 2026
Status
Open · checked 7d ago

About this role

Hinge Health is hiring a remote-friendly Staff Regulatory Affairs Engineer based out of the San Francisco headquarters to lead regulatory strategy for AI and machine learning medical software. This full-time role suits an experienced regulatory professional with a strong technical background in digital health and software submissions.

Role Overview

The Staff Regulatory Affairs Engineer functions as the primary regulatory strategist and technical architect for the artificial intelligence and machine learning Software as a Medical Device portfolio. This position treats regulatory affairs as a technical discipline involving hands-on authorship and management of regulatory filings including 510(k), De Novo, and Pre-Submissions. The professional collaborates closely with product, clinical, and engineering teams to interpret changing FDA frameworks for artificial intelligence and to maintain compliance within the quality management system.

Key Responsibilities

Lead the planning, authorship, and submission of regulatory filings such as 510(k), De Novo, and Q-Submissions for artificial intelligence enabled software products.
Develop and execute regulatory strategies for new product introductions and major software updates, serving as an internal authority on the FDA action plan for adaptive algorithms.
Participate in design reviews and change control boards to evaluate the regulatory impact of software adjustments and determine requirements for new filings or letters to file.
Support quality management system maintenance by ensuring compliance with standards such as 21 CFR 820 and ISO 13485 during internal and external audits.
Review and approve marketing materials, user manuals, and labeling to confirm claims match cleared indications for use.
Partner with quality teams to monitor post-market performance, assess complaints for reporting mandates, and manage necessary recalls or field actions.
Educate technical engineering teams on regulatory principles and help clarify how documentation directly supports regulatory clearance.

Requirements

Bachelor’s degree in biomedical engineering, software engineering, regulatory science, or a related technical or scientific field.
A minimum of four to six years of experience in regulatory affairs within the medical device industry, featuring at least three years focused on Software as a Medical Device or digital health.
Demonstrated track record of authoring and clearing United States FDA Class II submissions like 510(k) or De Novo, including direct interaction with FDA reviewers.
Technical fluency to understand software architecture, cloud infrastructure, and artificial intelligence or machine learning concepts, alongside familiarity with IEC 62304 and software validation guidance.

Nice to Have

Direct experience with regulatory submissions involving machine learning, deep learning, or computer vision, along with familiarity with good machine learning practice principles and predetermined change control plans.
Experience with international registrations, particularly European Union MDR for software or Health Canada requirements.
Ability to review statistical analysis plans and clinical validation reports to confirm alignment with regulatory expectations.
Experience working within agile and scrum environments to adapt submission timelines to iterative software release cycles.

Skills and Tools

Computer Vision
Software as a Medical Device (SaMD)
510(k) and De Novo Submissions
Quality Management Systems (21 CFR 820, ISO 13485)
IEC 62304 Compliance
AI/ML Regulatory Frameworks

Salary and Benefits

Annual salary range between $168,000 and $225,000 in USD.
Comprehensive medical, dental, and vision healthcare coverage including family support, gender-affirming care, fertility planning tools, and travel reimbursements.
Retirement planning options through traditional or Roth 401(k) plans featuring a two percent company match.
Modern life stipends to manage personal learning and professional development.

About the Company

Hinge Health uses software and artificial intelligence to automate joint and muscle health care, delivering improved member outcomes and reduced client costs. The platform addresses a broad spectrum of musculoskeletal care ranging from acute injury to chronic pain and post-surgical rehabilitation. Headquartered in San Francisco, California, the organization helps members engage in exercise therapy from anywhere to reduce surgery needs and drive health equity.

How to Apply

Interested candidates should visit the official Hinge Health careers page to submit their application and review relevant candidate privacy policies.

Skills and tech stack

Computer VisionDeep LearningMachine Learning

Questions candidates ask

What is the salary range for the Staff Regulatory Affairs Engineer role?

The annual salary ranges from $168,000 to $225,000 USD.

Where is the job located?

The role is based at the Hinge Health headquarters in San Francisco, California, with remote flexibility available.

What level of experience is required for this position?

Candidates need four to six years of overall experience in regulatory affairs within the medical device industry, with at least three years specifically focused on Software as a Medical Device or digital health.

What educational background is required?

A bachelor’s degree in biomedical engineering, software engineering, regulatory science, or a related technical or scientific field is required.

What specific technical submission expertise is expected?

Applicants must have a proven track record of authoring and clearing United States FDA Class II submissions such as 510(k) or De Novo, along with experience interfacing directly with FDA reviewers.

Ready to apply?

The application is on the official Hinge Health careers page.

Apply on company site