Medical Device Software Design & Compliance Engineer

Jobtailor; San Francisco (CA); On-site; USD 130,000 - 190,000; Full time

Job summary

Jobtailor in San Francisco seeks a Regulatory Documentation Specialist for medical device software. You will author and maintain Design History Files, Traceability Matrices, and software validation reports to support compliance with IEC 62304, ISO 14971, and FDA guidelines.

The role requires 5+ years in medical device software, a related bachelor’s degree, and a proven FDA clearance/launch track record. You’ll work with cross‑functional teams to keep regulatory documentation current and

Qualifications

• Experience writing, reviewing, and managing formal medical device software documentation (Design History Files, Traceability Matrices).
• Proven track record taking a medical device software product through FDA clearance/approval and launch.
• Deep familiarity with IEC 62304, ISO 14971, and FDA Software Validation Guidelines.

Responsibilities

• Author, review, and maintain design control documentation (Software Requirements, Architecture & Design Documents, Traceability Matrices).
• Ensure development processes align with IEC 62304, ISO 13485, and FDA 21 CFR Part 820 regulations.
• Produce software verification and validation protocols and reports with cross‑functional teams.
• Compile and organize documentation for regulatory submissions and post‑market surveillance.

Skills

Regulatory documentation

Regulatory compliance

Software validation

Version control

Education

Bachelor’s degree in CS / Biomedical Eng / Software Eng

Tools

Git

Jira

Greenlight Guru

Arena

Matrix Requirements

Jama

Job description

Jobtailor in San Francisco seeks a Regulatory Documentation Specialist for medical device software. You will author and maintain Design History Files, Traceability Matrices, and software validation reports to support compliance with IEC 62304, ISO 14971, and FDA guidelines.

The role requires 5+ years in medical device software, a related bachelor’s degree, and a proven FDA clearance/launch track record. You’ll work with cross‑functional teams to keep regulatory documentation current and