Compliance Documentation Engineer I/II

Applied Medical • Rancho Santa Margarita, CA

2d • Onsite

About The Position

The Compliance Documentation Engineer supports medical device compliance through the development, review, and maintenance of technical documentation. The role works closely with Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, and Engineering to help ensure products meet internal requirements, regulatory standards, and industry best practices throughout the product lifecycle. This is a collaborative, documentation-focused position requiring strong technical writing, attention to detail, and the ability to manage compliance activities across multiple projects. The position is expected to work on-site and contribute to a positive, supportive team environment.

The role develops and maintains design control documentation, engineering test protocols and reports, manufacturing instructions and test methods, risk management documentation such as FMEAs and hazard analyses, and regulatory and standards compliance assessments. It ensures documentation is complete, accurate, and aligned with internal procedures and regulatory requirements, and reviews standards and regulations for changes affecting device compliance.

The engineer coordinates documentation and compliance deliverables for project timelines and regulatory submissions, participates in design reviews, supports verification and validation activities, documents test results, and helps maintain risk management materials. The role evaluates compliance with standards and regulations including IEC 60601, ISO 13485, RoHS, and REACH, supports certification testing and interactions with external testing and certification bodies such as UL, and monitors regulatory and standards changes for potential product and documentation impacts.

Requirements

• Bachelor’s degree in Engineering or a related technical field.
• At least 1 year 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 and collaborate effectively across cross-functional teams.

Nice To Haves

• Experience with medical device design controls, risk management, and verification and 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.

Responsibilities

• Develop, review, and maintain design control documentation.
• Develop and maintain engineering test protocols and reports, manufacturing instructions and test methods, risk management documentation, and 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 that may affect device compliance.
• Collaborate with Quality, Regulatory Affairs, Clinical Affairs, Manufacturing, and Engineering on product development and compliance activities.
• Coordinate documentation and compliance deliverables to support project timelines and regulatory submissions.
• Participate in design reviews and help maintain alignment of design controls and risk management activities throughout development.
• Support device verification and validation activities and document test results.
• Assist with developing and maintaining FMEAs and hazard analyses.
• Support compliance assessments against applicable medical device standards and regulations.
• Evaluate product compliance with IEC 60601, ISO 13485, RoHS, and REACH.
• Support certification testing 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.

Benefits

• Training and mentorship with ongoing learning and development courses.
• On-campus wellness activities.
• Comprehensive medical, dental, and vision coverage.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.
• The total compensation package may include bonuses and/or other applicable incentive compensation plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level