Title : Senior Technical Writer
Location : North Carolina
Job Description :
- Lead the development, review, and management of comprehensive technical documentation, including Standard Operating Procedures (SOPs), Work Instructions (WIs), and qualification protocols (IQ, OQ, PQ)
- Serve as the primary point of contact for all documentation-related activities, ensuring that cross-functional teams (Engineering, Quality Assurance, Regulatory) are aligned and documentation is accurate, consistent, and complete
- Oversee the document review and approval process, maintaining strict adherence to FDA, GMP, and ISO 13485 : 2016 regulatory guidelines
- Manage document version control and maintain an organized document repository to ensure traceability, accessibility, and compliance
- Provide expertise in regulatory submissions, ensuring that all documentation is audit-ready and meets FDA standards for Class I and II medical devices
- Lead efforts to streamline and improve the documentation process, contributing to the development of documentation best practices
- Work closely with the Quality Management System (QMS) to ensure all documentation is in full compliance with internal policies and external regulations
- Mentor and guide junior team members or other technical writers as needed to ensure quality documentation across the team
Qualifications :
- Technical writing experience, with a strong focus on regulated industries such as medical devices, pharmaceuticals, or biotechnology
- Extensive experience working with FDA and ISO 13485 : 2016 standards, with a proven track record of delivering high-quality, compliant technical documentation
- Strong understanding of Good Manufacturing Practices (GMP) and experience in Quality Management Systems (QMS)
- Demonstrated ability to lead complex documentation projects, manage multiple priorities, and meet tight deadlines
- Excellent written and verbal communication skills, with the ability to present complex technical information clearly and concisely to various audiences
- Highly detail-oriented with a commitment to producing error-free documentation
- Strong leadership skills, with the ability to collaborate effectively within cross-functional teams and mentor junior staff
- Familiarity with electronic document management systems and change control processes in a regulated environment
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