As a Sr. Technical Writer in Regulatory Affairs at Philips Sleep & Respiratory Care (Philips SRC), I was responsible for developing and maintaining high-quality technical documentation for medical devices in compliance with regulatory requirements. This included creating documents such as regulatory submissions (e.g., 510(k), PMA, CE marking), instructions for use (IFUs), service manuals, risk management files, and labeling.
This role evolved from a contract position into full-time employment. I collaborated closely with the regulatory affairs team, as well as engineers, designers, and other product development team members, to ensure all documentation was accurate, complete, and fully compliant.
Sr. Technical Writer - Essential Duties and Responsibilities
This role involved the following:
- Develop and maintain technical documentation for medical devices in accordance with applicable regulatory requirements, including FDA, EU MDR, and other international standards.
- Collaborate with regulatory affairs, engineering, design, and other product development team members to ensure that all documentation is accurate, complete, and compliant.
- Write and edit IFUs, service manuals, risk management files, labeling, and other technical documentation.
- Review and revise documentation as needed to ensure that it is up-to-date and accurate. Provide training and support to internal and external stakeholders on the use of technical documentation.
- Stay up-to-date on the latest regulatory requirements and industry best practices for medical device technical writing.
- Strong understanding of FDA, EU MDR, and other international regulatory requirements for medical device technical documentation.
- Experience with submitting regulatory submissions, updating and maintaining IFUs, service manuals, risk management files, and labeling.
- Excellent writing and editing skills. Ability to work independently and as part of a team.
Sleepware G3
Sleepware G3 is diagnostic software, designed with benefits for sleep lab owners and technicians, including enhanced functionality, workflow, and performance efficiencies and is suited to the needs of a sleep lab. Matt was primarily resposnible for maintaining and updating the Sleepware G3 documentation. To do so Matt collaborated as part of software engineering team serving the role as the Sr. Technical Wrtier.
Note: The button below links to an external website, where the Sleepware G3 documentation can be publically acccessed. Due to its large file size, it not available from download on this website.