QA Compliance Technical Writer

Integra Lifesciences Holdings Corporation - Princeton, NJ

Full-time - Mid Level

Hybrid - Princeton, NJ

1,001-5,000 employees

Management of Companies and Enterprises

About the position

The Quality Compliance Technical Writer at Integra LifeSciences plays a crucial role in ensuring that the company's quality system documentation meets regulatory compliance standards. This position involves collaborating with quality system leadership and cross-functional teams to create and maintain quality system documentation that supports regulatory correspondence. The writer will serve as the primary author for responses to inquiries from external agencies, ensuring that all documentation is clear, concise, and adheres to regulatory guidelines. In this role, the Technical Writer will work closely with subject matter experts to develop robust correspondence and facilitate the creation of quality system documentation, including procedures, policies, and work instructions. The writer will also act as a liaison, guiding internal stakeholders on best practices for documentation writing and ensuring that all documents are authored using Integra's templates and style guides. Additionally, the Technical Writer will coordinate internal documentation reviews, lead project teams to consensus, and manage internal quality communications, including maintaining the quality system webpage and SharePoint sites. The role requires a strong focus on quality system record retention and the ability to write, format, edit, review, and proof documentation for both technical and non-technical users. This position is essential for maintaining the integrity of Integra's Global Quality Management System and ensuring compliance with regulatory requirements.

Responsibilities

• Collaborate with subject matter experts to develop robust and clear correspondence to external agencies.
• Facilitate the development of quality system documentation, actively participate in development and writing of quality system procedures, policies and work instructions.
• Serve as liaison and subject matter expert guiding and advising internal stakeholders on strategies and best practices for successful documentation writing.
• Author documents using Integra templates, style guides, and other guidance documents.
• Author documents per regulatory authority guidelines and requirements.
• Coordinate internal documentation reviews and successfully lead a project team to consensus.
• Coordinate internal Quality communications, including maintaining the quality system webpage, teams, and SharePoint sites as needed.
• Support quality system record retention.
• Write, format, edit, review and proof quality system documentation and regulatory correspondence for technical and non-technical users.
• Perform other responsibilities as required.

Requirements

• Bachelor degree with 8+ years of experience, Master degree with 5+ years of experience, Doctoral degree with 3+ years of experience or equivalent education and years of experience.
• Minimum of 5 years' experience in med device/pharmaceutical/biotech industry, with at least 5 years of experience as medical writer.
• Expertise with software and templates commonly used in regulatory medical writing (e.g., MS-Word, Excel, PowerPoint, Adobe Acrobat, EndNote, Reference Manager). Experience with MS-Project preferred.
• Medical device experience is preferred (510(k), PMA, BLA, HCTP).
• Advanced technical writing, presentation, bibliographic research and editorial skills.
• Strong ability to interpret and disseminate relevant product information.
• Strong organizational skills, attention to detail and proofreading skills. Demonstrated project management skills.
• Ability to produce reports and documents independently and evaluate the writing of others.
• Ability to rapidly develop expertise in the company's internal document management system.
• Works well and efficiently in fast-paced environment across multiple functional teams. Has solid understanding of the different clinical and regulatory development functional areas and roles.
• Positive, flexible, open-minded attitude; thrives in collaborative environment.
• Experience in design control processes is preferred.
• Comfortable leading teams and educating team members as needed during process of document development.

Nice-to-haves

• Experience with MS-Project preferred.
• Medical device experience is preferred (510(k), PMA, BLA, HCTP).
• Experience in design control processes is preferred.