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Regulatory Technical Writing Consultant

Posted on Feb 14, 2019 by Software Specialists

Monroeville, PA 15146
Health Care
Immediate Start
Annual Salary
Contract/Project

Description:

  • Responsible for creating/writing clinical evaluation documents (CEPs, CERs, PMCF plan) to demonstrate the safety and performance of medical products (Class I, IIa and IIb ) which are part of the current or planned Philips Respironics, Sleep and Respiratory Care (SRC) product portfolio:
  • Create CEPs, CERs and PMCF plans
  • Conducts reproducible, thorough, and objective literature searches.
  • Evaluates the contribution of the available clinical literature to establish performance and safety of therapeutic and diagnostic medical devices (products).
  • Extracts and relevant information clinical data and creates tables for data analysis
  • Reviews product risk information, device labeling, and product claims in light of device safety and performance information.

Skills

  • Experience planning and executing Internet literature searches using databases such as PubMed and EMBASE.
  • Deep knowledge of MEDDEV 2.7.1 Rev. 4 and EU MDR
  • Experience in updating CERs from MEDDEV 2.7.1 Rev. 3 to Meddev 2.7/1 Rev4
  • Understanding of research methodology and regulatory requirements
  • Excellent organizational and communication skills
  • Ability to work with multi-disciplinary teams
  • Ability to manage multiple projects with conflicting deadlines.
  • Ability to critically appraise and review clinical trial data from peer reviewed publications internal sources.
  • Ability to translate engineering and marketing data into a device performance context.
  • Knowledge of AMA writing guidelines;
  • Proficiency with computer programs such as MS Word, Excel and PowerPoint.
  • Experience with EndNote, SharePoint and SAP
  • Knowledge or experience in respiratory care and/or sleep medicine a plus

Reference: 646270114