We also have national recruiting centers that service our enterprise and MSP/VMS clients. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness. We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal. TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally.
Knowledge of regulations and standards affecting IVDs and Biologics. Ability to critically review own work before sending out for internal/external review by team.Good communication, interpersonal, and team skills.
#TECHLINK SYSTEMS MEDICAL WRITER SALARY SOFTWARE#
Good working knowledge of personal computer software programs in Windows environment.Fluent in word processing, flow diagrams and spreadsheets.Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.Good written and oral communication skills.Minimum 5 years in related areas such in Regulatory, Medical Writing, or equivalent experience with proficiency in 510(k) submissions (strongly preferred IVD experience).Bachelor's Degree in Science, Medical Technology, or equivalent experience.Works independently with little supervision.Consistently exceeds quality standards for accuracy and completeness.Provides on-going submission support to Regulatory Affairs by writing and submitting responses to FDA inquiries in the form of submission amendments.Arranges and conducts review meetings with teams on submission.Explains the data in a manner consistent with the target audience and regulatory requirements.Interprets and explains data generated from a variety of sources, including internal experiments, research documentation, charts, graphs, and tables.Confirms completeness of information to be presented.Understands sources of information to support US 510(k) regulatory submissions. Obtains relevant product data and information.Acts as interface, along with Regulatory Affairs, to resolve issues and questions arising during writing process.
Communicates deliverables needed and writing process to Cross Functional Team members.Coordinates all activities, in collaboration with Regulatory Affairs, related to the preparation and compilation of data and information into a single comprehensive package for US 510(k) regulatory submissions (strongly preferred IVD experience).
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