Job Description

Our client, an AI-powered cancer detection company dedicated to revolutionizing healthcare through personalized screenings, is currently seeking a Technical Writer to join them as a consultant. Working remotely, this person will be responsible for meticulously crafting clear, concise and consistent documentation that is well prepared for regulatory reviews, clearances, and compliance with FDA, CE MDR, and other global clearance needs.

Responsibilities:

• Develop clear and concise user manuals, instructional guides, and technical specifications that facilitate user understanding and engagement with complex products and services
• Work closely with subject matter experts to gather essential information and translate it into documentation that is comprehensible and accessible to the target audience, including regulatory bodies.
• Ensure all technical writing and documentation is meticulously prepared to meet the requirements and standards for regulatory reviews, clearances, and compliance with authorities such as FDA and CE MDR.
• Utilize documentation solutions to streamline the documentation process and maintain a structured system that aligns with global regulatory requirements.
• Uphold a strong commitment to excellence by adhering to stringent industry standards and continuously improving the quality of documentation

Qualifications:

• Bachelor’s degree in Life Sciences/Health Related Sciences or equivalent experience; masters degree preferred
• 5+ years of experience writing scientific, medical, or technical content, preferably in a clinical research setting
• Demonstrated understanding of clinical research, the software device development process, and applicable regulatory guidelines
• Strong Technical Writing and editing skills, proficient in translating technical concepts into understandable content, and creating technical documents that are well-organized and compliant with industry regulations.
• Ability to quickly gain a deep understanding of products and services, and has familiarity with medical device language, regulatory requirements, and documentation of medical software solutions.
• Familiarity with regulatory environments, including FDA, CE, MDR, and other international clearance expectations, requirements and processes. Excellent grasp of SOPs.
• Ability to effectively work with diverse teams, extracting and synthesizing detailed technical information.
• Experience with documentation organization and software to maintain a detailed database of reference materials.
• Strong attention to detail to ensure accuracy and clarity in all documentation efforts.

If you are interested in this position, please send your resume to [email protected]

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