Job Description
Requisition ID7112 -Posted -Nogales Plant I - MXN -Mexico -Quality Assurance, Regulatory & Compliance - Sonora
As an individual contributor, the function of the Regulatory Affairs Specialist is to support the Regulatory Affairs Department ensuring compliance with company standards and the applicable US and international medical device/drug regulations in which the company does business. The individual will prepare product submission documentation, evaluate design/manufacturing changes for effects on regulatory filings, and provide guidance to project teams as it relates to application of regulatory requirements. The individual will execute tasks and play a consultative role by partnering across internal business functions. The individual may also have/lead discussions with Regulatory Bodies.
ROLES AND RESPONSIBILITIES- SOP development and review
- Lead development of regional regulatory strategy and update stra...
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