Compliance Documentation Engineer I/II

Position Description

The Compliance Documentation Engineer plays a key role in supporting medical device compliance through the development, review, and maintenance of technical documentation. This position works closely with Quality, Regulatory Affairs, Clinical Affairs, and Engineering teams to ensure products meet internal requirements, regulatory standards, and industry best practices throughout the product lifecycle.

This is a highly collaborative and documentation-focused role requiring strong technical writing, attention to detail, and the ability to manage compliance-related activities across multiple projects.

Documentation & Compliance

• Develop, review, and maintain compliance documentation, including:
  • Design control documentation
  • Engineering test protocols and reports
  • Manufacturing instructions and test methods
  • Risk management documentation (FMEA, hazard analyses)
  • Regulatory and standards compliance assessments
• Ensure documentation is complete, accurate, and aligned with internal procedures and regulatory requirements.
• Review applicable standards and regulations and document changes impacting device compliance.

Cross-Functional Collaboration

• Partner closely with Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, and Engineering teams to support product development and compliance activities.
• Coordinate documentation and compliance deliverables to support project timelines and regulatory submissions.
• Participate in design reviews and help ensure design controls and risk management activities remain aligned throughout development.

Verification, Validation & Risk Management

• Support device verification and validation activities and document test results.
• Assist in the development and maintenance of risk management documentation, including FMEAs and hazard analyses.
• Support compliance assessments against applicable medical device standards and regulations.

Standards & Regulatory Compliance

• Evaluate product compliance with applicable standards and regulations, including:
  • IEC 60601
  • ISO 13485
  • RoHS
  • REACH
• Support certification testing activities and interactions with external testing and certifying bodies such as UL.
• Monitor changes to standards and regulatory requirements and assess potential impacts on products and documentation.

Position Requirements

Position Requirements:

• Bachelor's degree in Engineering or a related technical field.
• 1+ years of relevant experience in engineering, quality, regulatory, compliance, or medical device environments.
• Strong technical writing and documentation skills.
• Ability to interpret technical standards, procedures, drawings, protocols, and regulations.
• Strong organizational, analytical, and project management skills.
• Effective verbal and written communication skills.
• Ability to work independently while collaborating effectively across cross-functional team

Preferred

Preferred Requirements:

• Experience with medical device design controls, risk management, and verification/validation activities.
• Familiarity with IEC 60601, ISO 13485, RoHS, and REACH requirements.
• Experience with requirements management systems such as PTC or Jama.
• Experience working in a regulated medical device environment.
• Knowledge of electrical or software testing and documentation practices.

Benefits

The base compensation range for this role is $75000 - $95000 / year for the position in California. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries in California based on the date of this job posting. Your recruiter can share more about the specific salary range compensation package during your hiring process.

Please understand that the compensation range may be modified in the future. Each amount of pay is considered to be wages or compensation once such amount is earned and determinable. The amount and availability of any bonus, commission, benefit or any other form of compensation may be modified at the Company's sole discretion, consistent with the law.

The total compensation package for this position may also include [bonuses and/or other applicable incentive compensation plans].

Our total reward package also includes the following:

• Training and mentorship with ongoing learning and development courses
• On-campus wellness activities
• Comprehensive medical and dental and vision coverage
• Education reimbursement program
• 401(k) program with discretionary employer match
• Generous vacation accrual and paid holiday schedule