Medical Device CER Writer/ RA Specialist – REMOTE Job Vacancy in Madagoni LLC Trenton, NJ – Latest Jobs in Trenton, NJ

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Company Name : Madagoni LLC
Location : Trenton, NJ
Position : Medical Device CER Writer/ RA Specialist – REMOTE

Job Description : JOB DESCRIPTIONTitle: Medical Device CER Writer/ RA Specialist Project Description: Our client is a large medical device company and is looking to build a team of people to help with the remediation efforts required to update their technical files from MDD – MDR.Day to Day Responsibilities: This consultant will be responsible for updating technical files and design dossiers to meet the new EU MDR requirements. The person chosen for this role will need to have an in depth knowledge of both EU MDD and EU MDR. They will be working with a small regulatory team, and will be expected to accommodate different time zones.This person will also be identifying any gaps within their CER’s, and then updating the CER’s from MDD – MDR. They will initially be doing this for class I devices then transitioning to their class II devices. After the CER efforts are complete there will be a labeling remediation aspect.Required Skills: Regulatory AffairsEU MDR/EU MDDTechnical FilesCERLabeling RemediationJob Types: Full-time, ContractSalary: $40.00 – $50.00 per hourSchedule:8 hour shiftEducation:Bachelor’s (Preferred)Experience:Writing skills: 1 year (Preferred)Speak with the employer+91 7036886795

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