Technical Writer jobs in Clay, NY

One of Robert Half's Fortune 500 Medical Device clients is hiring a Technical Writer for a long-term, remote contract. If you have 2 years of EU MDR submission experience from a technical writing standpoint, apply today!

Essential Duties and Responsibilities:

• Draft verification and validation test protocol and reports (e.g. summary and conclusions sections) to be included in medical device design history files and technical files.
• Draft key technical documentation to support regulatory submissions (e.g. 510ks Q-Subs etc. for FDA EU and other regulatory body submissions) including sections for device, description, software, cybersecurity, human factors, electrical safety, electromagnetic compatibility, biocompatibility, sterility, cleaning, clinical, testing and studies and performance testing.
• Collaborate with key SMEs within Engineering, Human Factors, Design Assurance, Regulatory Affairs and other groups to understand product technical documentation and development history.
• Use effective project management strategies and tools to meet project milestones, support product release dates, and satisfy quality standards.
• Demonstrate exceptional information-gathering analysis and documentation development skills.
• Adhere to Baxter writing standards and style guides.
• Create draft documents applying appropriate standards, regulatory guidance, and corporate subject matter expertise to synthesize, organize, and clarify technical content to be included in regulatory submissions.
• Gather feedback from key stakeholders to support creation of a comprehensive technical dossier for submission to regulatory agencies.
• Manage regular meetings to request documentation, develop documents, gather feedback, and finalize content for RA to incorporate in regulatory submissions.
• Schedule peer reviews to ensure documentation is accurate, relevant, concise, easy to use, and conforms to style guide writing standards and BAXTER quality metrics.
• Maintain in-process work in shared workspaces as appropriate and archive finished work according to Baxter document control requirements.