Remote: Medical Writer (CER for EU MDR)

Life Sciences & Technology | Clinical Research & Clinical Affairs

Job Description: 

A Black Diamond client is looking for a medical writer to help update their CER’s under MEDDEV 2.7.1. This individual will be responsible for reviewing and completing CER’s and must have recent experience authoring CER’s to meet EU MDR compliance requirements. The client has multiple CER’s that they need to update and complete before the 2021 CER deadline. Experience writing CER’s for Class III Orthopedic products are highly desired; spinal experience is a huge plus. Any additional experience with PMCF writing would be a huge benefit. Candidates will need to give an accurate timeline of how long it takes for them to complete a CER – the client is looking for a consistent timeline with their’s: 30-60 days, depending on the complexity. 

  • Recent EU MDR CER writing experience
  • Working knowledge of EU MDR CERrequirements
  • CER MEDDEV 2.7.1 REV 4 Experience
  • Experience with CER submission s
  • Orthopedic experience require
  • Spine experience beneficial
  • Ph.D. preferred 

 

 

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Remote: Medical Writer (CER for EU MDR) (228004)

Start Date
ASAP
Location
Remote, United States

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