Job Description: Position Summary:

The Technical Writer II is responsible for supporting the Quality Assurance and Regulatory Affairs teams by creating, revising, and maintaining documentation related to IVDR submissions. This role works cross-functionally with Manufacturing, Operations, and Project Management teams to address documentation gaps, revise documents, submit ECOs, and maintain project timelines to meet regulatory compliance requirements.

Job Responsibilities

• Work cross-functionally with other teams to create or revise documentation via the established document control process.

• Review and recommend revisions or changes in scope, format, and content to existing documentation. Maintain records and files of work and revisions.

• Work closely with Quality Assurance to ensure that the documentation implemented is compliant with regulatory requirements.

• Maintain strict compliance with Quality Management System requirements, ISO 13485, cGMP, QSR and other applicable regulations and/or standards.

• May be called upon the implement procedural changes supporting continuous improvement initiatives.

• Respond to Quality action related to CAPAs, SCARs or nonconformances.

• Proof-read and provide feedback on documentation prepared by other departments.

• Organize large amounts of technical information utilizing Advanced MS Word and Excel functions as well as manage many technical documents simultaneously.

• Ability to work independently and collaborate with cross functional teams to identify appropriate content updates as required.

• Participate in cross functional documentation projects as required.

• Keep functional leadership and/or project management appraised project status.

• Additional tasks as assigned.

Ideal Candidate Preferred Qualifications

• Effective communication skills and the ability to collaborate with cross-functional teams

• Education: B.S./B.A. in a scientific discipline (e.g. chemistry, chemical engineering, biology, bioengineering, etc.). Preference is given to candidates with technical writing and scientific background.

• Experience (minimum): 2 - 5 years’ experience in a regulated environment (ISO 13485, FDA QSRs, GMP or IVDs)

• Ability to work independently with guidance from leadership, and as part of a team;

• Manage multiple activities, and adjust to changing priorities in a dynamic, FDA-regulated environment.

• Strong attention to detail, and ability to understand technical terminology and complex processes.

• Experience in using an electronic Document Management System as a Technical Writer.

• Must be computer literate and competent in PC based software such as Office 2010 Professional (Word, Excel, Access, and PowerPoint).

• Must be organized and detail-oriented to be able to prioritize own and other’s work and meet business productivity metrics.

• Proofreading and editing skills, and an aptitude for numbers and detail-oriented work requiring a high degree of accuracy.

• Must have excellent customer service and listening skills.

• Basic arithmetic skills including the ability to calculate figures and amounts and to interpret the data.

• Able to sit, stand and/or use keyboard for long periods of time.