-
ID
#11990620 -
Job type
Permanent -
Salary
TBD -
Source
Genesis10 -
Date
2021-04-07 -
Deadline
2021-06-06
Technical Writer II
California, Paloalto, 94301 Paloalto USAPermanent
Vacancy expired!
- 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.
- 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.
- 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)
- 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.
Vacancy expired!
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