Specialist, RAQA at The Judge Group Inc. in Portage, Michigan

Job Description:

Location: Portage, MI

Salary: $60.00 USD Hourly - $68.00 USD Hourly

Description: Our client is currently seeking a Specialist, RAQA for a 6 month + contract.

As a Regulatory Affairs Associate, EUDAMED (Contractor), you will primarily be responsible for supporting compilation/review/submission of unique device identifier (UDI) data attributes to the European Union's EUDAMED medical device database for primarily class I products.


Your responsibilities will include:


*Updating UDI and BUDI records to ensure all mandatory attributes fields are entered in QuickBase, using a variety of source material and liaising with other departments when necessary (clinical affairs, engineering, etc.).


*Submitting any finalized UDI records to EUDAMED utilizing the Reed Tech Single Source application.


*Maintaining excel records of all site-level UDI and BUDI attributes and make updates if needed. *Developing, alongside the UDI site process owner, a working aid for maintenance of UDI records over time as it relates to change control.


*Reporting out progress to management of record submission on a monthly basis.


*Bachelor's degree in Engineering, Science, or related degree.


*Proficiency in using MS Excel and other MS Office applications.


*Good communication and co-ordination skills are required to liaise with internal and external colleagues and service providers.


*Good planning and time management skills.


*Team player, with excellent administration skills.


*Knowledge of EU MDR is a plus.


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Contact: eronan@judge.com


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