- Provide documentation and logistics support for a variety of activities working in an IMDRF/ISO regulated environment.
- Collaborate with Compliance & Strategy and Architecture & Design teams to research, plan, write, edit, and maintain technical documentation
- In charge of metadata review and workflow initiation in an electronic documentation management system, adhering to specific FDA, EMA, IMDRF requirements for documentation.
- Consult with engineering, quality assurance, technical support, and product management to update existing documentation and write new platform and product documentation
- Entrusted to initiate, oversee and give guidance on Design Change Requests using high-level access Quality Management software to improve platform and product quality, achieve regulatory compliance and reduce risk
- Manage highly confidential documents in hard copy format as well as log sheets to maintain traceability, prevent misuse and help with prevention/response to CAPAs.
- Managed content development process by coordinating with engineering team to track product changes and schedules and communicating changes
- Maintain a comprehensive library of technical terminology and documentation
- Manage updates and revisions to technical literature
- Edited style guide for consistency
Summary of Qualifications:
- Bachelor’s Degree in Biochemistry, Biotechnology or related field
- Proven experience working in a technical writing position
- Excellent written and verbal communication skills
- Proficiency in MS Office
- Strong attention to detail
- Able to write in explanatory and procedural styles for multiple audiences
- Skilled at prioritization and multitasking