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iMPact Business Group
https://cdn.haleymarketing.com/templates/62439/images/impact-200x200.png
http://www.impactbusinessgroup.com
http://www.impactbusinessgroup.com
USD
70.00
70.00
HOUR
true
R&D Technical Writer
Posted: 06/10/2025
2025-06-10
2025-07-14
Job Type:
Contract
Industry: Other (HR, Admin, Mkt, Sales)
Job Number: 26339
Pay Rate: $ 70.00 - $ 70.00
Job Description
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Regulatory R&D Technical Writer for a 6-month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail-oriented Top Talents in an extremely collaborative and professional environment.
As part of R&D, the R&D Technical Writer is responsible for creating end-user regulatory compliant 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.
Position Description (Principle Duties and Responsibilities)
- 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
- 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, services, technology, test method, and documents in the clearest, most logical way for the greatest reader comprehension
- Fully support the Quality Policy by building quality into all aspects by maintaining compliance with all quality requirements and supporting improvements that make it easier for the organization to maintain compliance in complex areas
- 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
- Drives continuous improvement (NCs and CAPAs) and assessment of current procedures, generation of quality plans and identification of best practices
- Contributes to process improvements and drives key areas of strategic programs that implement improved processes to reduce error rates.
Job Requirements
Educational/Experience Requirements
- 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:
- Bachelor's 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
- 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
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