Regulatory Technical Writing Consultant
Posted on Feb 14, 2019 by Software Specialists
- 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.
- 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