Role Overview:
As a Regulatory Affairs Associate, you will provide key support in managing and maintaining regulatory data records, ensuring accuracy and compliance with relevant databases and regulatory standards. You will collaborate with cross-functional teams to compile, review, and submit required data, while also ensuring that records are updated and maintained over time. This role requires a detail-oriented and organized individual who can work independently with minimal supervision while ensuring that all regulatory requirements are met.
What you will do
:As a Regulatory Affairs Associate, you will primarily be responsible for supporting compilation/review/submission of unique device identifier 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
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What you nee
- d:Bachelor's degree in Engineering, Science, or related degre
- e.Proficiency in using MS Excel and other MS Office application
- s.Good communication and co-ordination skills are required to liaise with internal and external colleagues and service provider
- s.Good planning and time management skill
- s.Team player, with excellent administration skill
- s.Knowledge of EU MDR is a plu
s.