Randstad Technical Writing Consultant - EU MDR in Monroeville, Pennsylvania

Technical Writing Consultant - EU MDR

job details:

  • location:Monroeville, PA

  • salary:$60 - $70 per hour

  • date posted:Monday, February 11, 2019

  • job type:Contract

  • industry:Professional, Scientific, and Technical Services

  • reference:669881

job description

Technical Writing Consultant - EU MDR

job summary:

Randstad is looking for a Remote Tech Writer

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 company, Sleep and Respiratory Care (SRC) product portfolio:

location: Monroeville, Pennsylvania

job type: Contract

salary: $60 - 70 per hour

work hours: 8am to 5pm

education: Bachelors

responsibilities:

o Create CEPs, CERs and PMCF plans

o Conducts reproducible, thorough, and objective literature searches.

o Evaluates the contribution of the available clinical literature to establish performance and safety of therapeutic and diagnostic medical devices (products).

o Extracts and relevant information clinical data and creates tables for data analysis

o Reviews product risk information, device labeling, and product claims in light of device safety and performance information.

qualifications:

  • 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

skills: 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.

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.