Job title: USA – Technical Writer III
Company: Staffing the Universe
Job description: Job Description
Background in Regulatory required, Hybrid between Regulatory and Technical Writing
Job description: Regulatory Technical Writer
Fully remote; full-time; contract-to-hire. US applicants only.
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., 510(k)s, 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 (RA), 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.
Qualifications:
5+ years of experience in technical writing and editing for the medical device industry.
Evidence of successful drafting of technical documentation for 510K and/or MDR/MDD submissions.
Thorough knowledge of the English language, including grammar, spelling, mechanics, and usage.
Working knowledge of applicable standards in electromechanical medical device diagnostics (vitals), software, cybersecurity, human factors, electrical safety, electromagnetic compatibility, biocompatibility, sterility, clinical testing and studies, performance testing, and device descriptions.
Exceptional skill and facility creating clear and comprehensive documentation marked by strong organization, strategic selection of detail, and overall presentation that promotes understanding by technical and non-technical readers.
Meticulous attention to detail.
Engineering or scientific background a plus.
Expected salary: $63.22 – 70 per hour
Location: Skaneateles, NY
Job date: Thu, 21 Sep 2023 04:41:59 GMT
