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Job Details

Medical Device CER Writer Remote

Company name
ALKU

Location
Chicago, IL

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Profile

Background: 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. Project: 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\u2019 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. Required: CER Writing Meddev 2.7.1. Rev 4 Class I and IIa-IIb Devices Job Type: Contract

Company info

ALKU

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