Compliance Documentation Engineer I/II
Applied Medical
Summary
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.
Job description
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), 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 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, and 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.
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 teams.
Benefits
- Training and mentorship
- Learning and development courses
- On-campus wellness activities
- Medical, dental & vision coverage
- Education reimbursement
- 401(k) with employer match
- Generous vacation accrual
- Paid holidays
- Bonus and incentive compensation
Company overview
Applied Medical is a leading medical device company specializing in the development and manufacturing of advanced surgical instruments and minimally invasive surgical technologies. Founded in 1987 and headquartered in Rancho Santa Margarita, California, the company has established itself as a prominent player in the surgical device industry. Applied Medical focuses on creating innovative products for various surgical specialties including general surgery, gynecology, urology, and cardiothoracic procedures. The company is particularly known for its expertise in trocars, access devices, and other critical surgical instruments used in laparoscopic and minimally invasive surgeries. With a strong commitment to quality and innovation, Applied Medical operates with a vertically integrated manufacturing model that allows for greater control over product development and quality assurance. The company serves healthcare providers worldwide, offering comprehensive solutions that enhance surgical outcomes while reducing healthcare costs. Applied Medical's dedication to advancing surgical technology has positioned it as a trusted partner for surgeons and healthcare institutions globally.