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Regulatory Affairs Assistant at Medical Device Company-1 year experience-Boston
*Developed Quality Assurance and Regulatory Affairs processes, and managed databases. *Familiarity with medical device regulations, standards: ISO 13485 and FDA guidances *Support the submittal of product regulatory filings and maintenance with focus on US 510(k), EU technical files. *Review design control documents including protocols and reports associated with design inputs and outputs. *Interested in international medical device import/exporting process complying with FDA and international regulatory laws and standards. *Fluency in English, Italian, Turkish and conversational Spanish. *Available to relocate nation wide.
Quality Coordinator
About Me
Industry: |
Healthcare & Medical |
|---|---|
Occupation: |
Quality Coordinator |
Education level: |
Master |
Will Relocate: |
Yes |
