Requisition ID****-Posted -Nogales Plant I - MXN-Mexico-Quality Assurance, Regulatory & Compliance-SonoraAs 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 RESPONSIBILITIESSOP development and reviewLead development of regional regulatory strategy and update strategy based upon regulatory changes with limited supervisionDetermine and ...