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DATE ADDED: Wed 17/10/2018

Regulatory Affairs Coordinator

Sparks Glencoe, USA
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COMPANY: RAMSOFT SYSTEMS, INC.

Job Description
  •  The Translations Coordinator is responsible for coordinating translation requests for products marketed by  Life Sciences. This function’s responsibilities include: redlining, proofreading, ordering and inspecting multilingual instructions for use, interacting with Regulatory Affairs, Labeling Specialists, Technical Writers, and Translations Team members plus working closely with translation vendors to ensure high quality and cost-effective translations. This position requires a detail-oriented, independent worker who provides status reports to the Label Design & Development Team. 
  • Responsible for coordinating multilingual translations projects: initiates, maintains, and audits projects to ensure stipulated completion dates are met. 
  • Develops and maintains project schedules, query cycles, and linguistic QA required to achieve project accuracy and completion. 
  • Maintains Translations Management site and email box for incoming and outgoing product/platform language requests. 
  • Tracks translation invoices and allocates charges to appropriate accounts. 
  • Collaborates with relevant stakeholders to resolve questions or conflicts related to source file discrepancies, terminology, language quality, and workflow. 
  • Assists in maintaining terminology glossaries and translation memories. 
  • Proofreads multilingual documentation. 
  • Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements; participates as required in training on regulatory issues affecting own area of work; brings regulatory compliance questions/issues to the attention of management. 
  • Communicates effectively with all levels of management, business units (Corporate and International), and possesses a high degree of flexibility/selectivity in prioritizing business units and plant projects to meet established goals. 
  • Participates in the activities of professional and trade organizations through attendance at meetings. 
  • Promotes a safe work environment and may provide recommendations on maintaining the safety of the work environment. 
  • Administration of other policies and programs as may be determined to be within the purview of the Labeling Design and Development Department. 
     


Role: Regulatory Affairs Coordinator
Job Type:
Location: Sparks Glencoe,

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