QA Compliance Technical Writer

Integra Life Sciences - Princeton, NJ

Full-time - Mid Level

Princeton, NJ

1,001-5,000 employees

Miscellaneous Manufacturing

About the position

The Quality Compliance Technical Writer at Integra LifeSciences is responsible for creating and managing quality system documentation to ensure regulatory compliance. This role involves collaboration with various stakeholders to develop clear correspondence for external agencies and to facilitate the documentation process within the Global Quality Management System.

Responsibilities

• Collaborate with subject matter experts to develop robust and clear correspondence to external agencies.
• Facilitate the development of quality system documentation, including procedures, policies, and work instructions.
• Serve as a liaison and subject matter expert for internal stakeholders on documentation strategies and best practices.
• Author documents using Integra templates and style guides, adhering to regulatory authority guidelines.
• Coordinate internal documentation reviews and lead project teams to consensus.
• Maintain internal Quality communications, including quality system webpages and SharePoint sites.
• Support quality system record retention.
• Write, format, edit, review, and proof quality system documentation and regulatory correspondence.

Requirements

• Bachelor's degree with 8+ years of experience, Master's degree with 5+ years of experience, or Doctoral degree with 3+ years of experience in a relevant field.
• Minimum of 5 years' experience in the medical device, pharmaceutical, or biotech industry, with at least 5 years as a medical writer.
• Expertise with software and templates used in regulatory medical writing (e.g., MS-Word, Excel, PowerPoint, Adobe Acrobat).
• Advanced technical writing, presentation, bibliographic research, and editorial skills.
• Strong organizational skills, attention to detail, and proofreading skills.

Nice-to-haves

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

Benefits

• Hybrid work environment between Princeton, NJ and remote work options.