Technical Writer

Scope of Job
The R&D Technical Writer is responsible for preparing documentation for IVDR product compliance. Work closely with development and support organizations to write and edit documentation for products. Write plans and reports that explain scientific and technical information in simple language.
Primary Responsibilities

• Review current product data and reports to create document deliverables for IVDR remediation.
• Understand basic system functionality and operation of instrumentation.
• Develop a basic level of understanding of the company's products, applications and markets.
• Ability to recognize gaps in data and develop strategies to fulfill the regulatory requirement.
• Write the documentation according to the audience (e.g. FDA, Medical Technology, etc.) and technical content defined in the documentation plan.
• Work with project managers and subject matter experts to determine documentation requirements.
• Ensure consistency, completeness, accuracy, and conformance to style guidelines.
• Collaborate with the team to manage project related tasks within MS Project
• Generate metrics of testing execution status
• Maintain records and files of work and revisions according to procedures and processes.
• Exhibit strong initiative and is willing to accept challenging projects.
• Utilize existing documentation as a reference for enhancement and development of new documents.
• Write clear, concise and informative documentation.

Qualifications
4-5 or more years of experience of Technical Writing within a regulated environment
Able to demonstrate both technical writing and project management/coordination experience.

4  yrs at least on IVDR.

• Proficient with Microsoft Word and SharePoint
• Excellent communication skills, both verbal and written
• Detailed knowledge of the general computerized system development life cycle in a regulated environment and software quality assurance
• The ability to work both independently and with teams at various levels in the organization.
• Excellent organizational skills and attention to detail and accuracy

Education & Certifications

• BS/BA degree preferred