Regulatory Affairs - Fremont, United States - Dexian
Description
Details:
Job Title: Lead Analyst, R&D Technical Writing
Duration: 12 Months contract
Location: Fremont CA 94538
Pay Range: USD 65.00 USD 70.00/hr.
Description:
As part of Sustaining R&D, the Lead Analyst, R&D Technical Writing is responsible for creating end-user regulatory complaint product labeling.
The specialist contributes to new product development and design change (sustaining) activities in the areas of labeling design/release, technical writing, translation management, development of artwork/images and development or improvement of processes for improved efficiency and compliance.
This role will engage with cross functional teams to resolve obstacles effectively, be responsible for meeting key labeling objectives, and lead/collaborate on continuous improvement initiatives or special activities having business impact.
4-6 years of relevant experience in developing or delivery of technical publications that are part of products including writing, graphic design, development of artwork/images, document control, related to engineering, with part of experience in a medical device/regulated industry
Bachelors Degree in Graphics or Language or equivalent experience (Advanced degree may be considered towards years of experience)
Required to have a high level of service and responsibility in managing highly detailed and varied workload from internal customers and be comfortable working to tight timelines
Provide weekly summary of activities, create project plans, prioritize, and effectively communicate updates to customers Follow Good Document practices (GDP) for all documentation created/reviewed and staying current on all required training for incumbent position
Subject Matter Expert (SME) in Microsoft Applications (Word, Excel, PowerPoint, and Visio), Adobe Suite (InDesign, FrameMaker, Photoshop, and Illustrator) Demonstrated experience in the following: Instructions for Use, Training Guides, Support of Electronic IFU (eIFU) and website, Translation management Required Software
Microsoft applications (Word, Excel, PowerPoint, and Visio)
Adobe Suite (InDesign, Frame Maker, Photo Shop, and Illustrator)
Experience in website design and testing
For Label Designer Role: Database driven labeling system such as Prisym ID, Label View, Loftware, Bartender Nice Label, and Easy Label, Computer Aided Drafting (CAD) Solidworks, AutoCAD
In the field above,: are workers who are hired for a specified or limited amount of time, paid through a third party.
Strong attention to detail, reviews and audits other technical publications deliverables and consistently delivers quality documentation with no escapes
Leads structured problem-solving initiatives to resolve complex technical issues and document within appropriate quality system documentation
Drives creation of training and communication materials that can be used by self or other staff to convey new or updated processes.
As regulations change and quality systems are merged/aligned, execute the creation/refinement of department and quality system SOPs, Work Instructions, forms, and templates that have considerable graphical content with minimal supervision
Researches and builds knowledge about products, service, technology, test method and documents in the clearest, most logical way for greatest reader comprehension
Fully support the Quality Policy by building quality into all aspects by maintaining compliance to all quality requirements and supporting improvements that make it easier for the organization to maintain compliance in complex areas
Prepare for internal and external audits by gathering records, supporting backroom, and providing explanation for design areas developed by self with auditor in the Front Room
Lead recertification and other compliance projects by managing key activities with stakeholders to execute required changes and sometimes determine alternate design directions
Demonstrated extensive application of knowledge through delivery of high-quality deliverables (SOPs, technical literature and Work Instructions, engineering work product) to ensure continuity of content style that meets applicable standards and is appropriate for its intended audience
Provides input to creation of training and communication materials that can be used by self or other staff to convey new or updated processes
Experienced in modifying existing and creating new Quality System documentation (work instructions, standing operating procedures, forms, checklists, and templates)
Drives continuous improvement (NCs and CAPAs) and assessment of current procedures, generation of quality plans and identification of best practices
Advocates for creation or change in procedures and with complementary procedures owned by others, along with appropriate technical rationale to support recommended changes.
Contributes to process improvements to and drives key areas of strategic programs that implement improved processes to reduce error rates.
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.
Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit to learn more.
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status