Genesis10 is currently seeking a Technical Writer with our client in the SEO industry in their Palo Alto location. This is a 10 month + contract position.
Summary:
The client's product area includes experts from across the company who are leveraging expertise in AI, hardware, products and more in order to help people lead healthier lives.
The Customer Success team is responsible for assisting and maintaining relationships with healthcare providers and other clients who use our tools.
This role will create a range of different documents to help the team achieve regulatory approval and launch products with partner healthcare institutions.
Responsibilities:
This role will collaborate closely with leaders from product, engineering, operations, legal, regulatory, and customer success teams. This role is responsible for writing user-facing documents and ensuring they are accurate, complete, and compliant with regulatory standards.
Research products and work with subject matter experts to fully understand regulatory implications, correct usage, processes, and top user issues.
Create all of the following materials: instructions for use (IFUs), non-IFU user manuals, API integration guides, standard operating procedures (SOPs), work instructions (WIs), and other user- or partner-facing product descriptions.
Ensure documents comply with regulatory standards in the United States (CFR 21 801/820), Europe (ISO 13485, MDR), and other worldwide regulatory bodies as needed.
Work with a wide range of cross-functional stakeholders to review documents, execute on feedback, and gain final sign-off.
Create basic graphics to supplement written content.
Organize and optimize the corpus of documentation within content management systems.
Manage own assignments and workflow.
Facilitate the localization process for documents (however, no direct translation required for this role).
Create all of the following materials: instructions for use (IFUs), non-IFU user manuals, API integration guides, standard operating procedures (SOPs), work instructions (WIs), and other user- or partner-facing product descriptions.
Ensure documents comply with regulatory standards in the United States (CFR 21 801/820), Europe (ISO 13485, MDR), and other worldwide regulatory bodies as needed.
Work with a wide range of cross-functional stakeholders to review documents, execute on feedback, and gain final sign-off.
Qualifications:
4+ years direct experience writing and copy editing regulatory materials:
Language: U.S. English
Audiences: Developers, healthcare professionals, medical device users, and general public
Industry: Medical software or other related healthcare segment
Compliance: ISO 13485, ISO 14971, FDA 21 CFR 820.30, FDA 21 CFR 801 (and related FDA labelling guidance), MDR compliance. QMS: 21 CFR 820 and ISO 13485-compliant
Quality Management System. 4+ years direct experience creating technical support documents
Knowledge management: Documents maintained in a content management system such as Zendesk, Atlassian Confluence, Google Connect Composer
Experience creating technical graphics using image editing software such as Photoshop, Illustrator, GIMP Demonstrated track record of attention to detail, organization, and time management
Ability to manage multiple stakeholders and balance multiple competing priorities
Ability to communicate clearly with cross-functional teams
Ability to participate fully in discussions about process and best practices that extend beyond day-to-day task completion
Able to work as a W2 employee of Genesis10 (no Corp-to-Corp)
Desired:
4+ years experience organizing and optimizing a large corpus of documentation in a system such as a knowledge base for easy access and usability.
Experience using page layout software such as Adobe InDesign.
If you have the described qualifications and are interested in this exciting opportunity, apply today!
About Genesis10: Genesis10 is a leading U.S. business and technology consulting firm with hundreds of clients needing proven talent and solutions to power their strategic initiatives. If you are a high performing business or IT professional with solid, referenced experience, we want to meet you. Genesis10 recruiters and delivery professionals are highly accomplished career advocates, who get to know you beyond your resume to position you with the opportunities that fit your skills, experience and aspirations. We have benefit options to fit your needs and a support staff that works with you from placement throughout your engagement project after project. To learn more about Genesis10 and to view all our available career opportunities, please visit us at www.genesis10.com "Genesis10 is an Equal Opportunity Employer, M/F/D/V
