Savannah Arthur
- Role
- Regulatory Affairs Specialist at Cook Medical
- Location
- Winston-Salem, NC, US
- LinkedIn followers
- 500 followers
About Savannah Arthur
Regulatory Professional / Engineer with more than 3 years of experience in medical device…
Experience
Regulatory Affairs Specialist
Feb 2021 — Present
I work with a team of the ever-changing legislation in all regions in which a medical device company wishes to distributes its products. • collecting, collating, and evaluating scientific data • oversee design change projects during the lifecycle of current products • write and develop templates and procedures that are in accordance to European Union Medical Device Regulations (EUMDR) • build and submit technical files for EUMDR to sustain compliance to FDA regulation standards • present registration documents to regulatory agencies and carry out any negotiations necessary for market authorization • create and build flowcharts in Microsoft Visio • write 510k’s and 519’s change notifications to affected regulatory agencies
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