Medical Device CER Writer (Remote)

Chicago, IL

Job ID: 131104 Industry: CLINICAL

Medical Device  CER Writer (Remote)



The client is a medical device company looking to bring in a consultant to help them update their CER files to Meddev Rev 4 standards. They currently work with class I and class IIa-IIb devices. The client needs them to work through 30 CERs that are currently out of compliance.


This person will be responsible for updating the CERs to Meddev 2.7.1. Rev 4 standards. They are expected to work with the client’ s regulatory and clinical team to organize the most efficient practice for updating the CERs. This person must have experience updating CERs from Rev 3 to Rev 4. If this person has experience writing new CERs from scratch in compliance with Rev 4 that would be ideal. This client primarily works with low risk devices so that experience would be preferred.


CER Writing

Meddev 2.7.1. Rev 4

Class I and IIa-IIb Devices

Job Type: Contract  

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