AI/ML SaMD Regulatory Lead: Submissions & Strategy

Hinge Health; San Francisco (CA); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Family and fertility planning tools

Traditional or Roth 401(k) with 2% company match

Support for continuous learning and development

Job summary

A healthcare technology company in San Francisco is seeking a Staff Regulatory Affairs Engineer. The role involves leading regulatory submissions for AI/ML software, developing regulatory strategies, and ensuring compliance with FDA regulations. The ideal candidate has over 7 years in Regulatory Affairs, particularly in Medical Devices, and is skilled in managing AI-specific regulations. Comprehensive benefits include inclusive healthcare coverage and a 401(k) with a company match.

Qualifications

• 7+ years of experience in Regulatory Affairs within the medical device industry.
• Minimum of 3 years focused on Software as a Medical Device (SaMD) or Digital Health.
• Proven track record of authoring US FDA Class II submissions.

Responsibilities

• Lead regulatory filing submissions for AI/ML-enabled software.
• Develop regulatory strategies for new product introductions.
• Support maintenance of the Quality Management System.

Skills

Regulatory Strategy

Submission Leadership

Technical Fluency in AI/ML

Cross-functional Coaching

Education

Bachelor’s degree in Biomedical Engineering, Software Engineering, or related field

Tools

IEC 62304

FDA Guidance on Software Validation

Job description

A healthcare technology company in San Francisco is seeking a Staff Regulatory Affairs Engineer. The role involves leading regulatory submissions for AI/ML software, developing regulatory strategies, and ensuring compliance with FDA regulations. The ideal candidate has over 7 years in Regulatory Affairs, particularly in Medical Devices, and is skilled in managing AI-specific regulations. Comprehensive benefits include inclusive healthcare coverage and a 401(k) with a company match.