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Regulatory Affairs Representative-Oracle Implementation

Company: Volt Services Group
Location: Santa Clara
Posted on: August 1, 2020

Job Description:

In need of a Regulatory Affairs Specialist who can represent a cross functional team during an Oracle Agile software implementation. This person must have experience in an ISO13485 regulated environment. Roles and Responsibilities Serve as the regulatory representative for Oracle Agile software implementation. Participate in Oracle Agile software workshop and meetings associated with Product Governance Compliance (PGC) workstream consisting of global trade compliance, material hazards and risks. Product governance compliance workstream includes Hardware - RoHS, WEEE, REACH Compliance Track Substance Volume by Shipment, Chemicals - Reporting, Registrations Notifications, Permits, Licenses, Certificates, Declarations, Precursor Controlled Substances Review requirements related to product classification, SDS management, substance volume tracking, hazardous material management and global label management. Lead system-wide testing of standard and custom functionality in the Oracle Agile Platform Develop and document a detailed suite of test cases to be used during integration, SIT regression, and UAT testing Prior experience testing CRM andor ERP technologies (e.g. Oracle, Oracle NetSuite SAP, Salesforce) supporting in a biotech environment Experience writing manual and automated test scripts Must have a Bachelors or Master39s Degree or equivalent in Biological science or equivalent. Must have hands on experience agile oracle test writing and executing validation protocols and reports for the medical device industry. Must have experience in an ISO13485 and Chemical, Biological and Animal Origin product governance knowledge. Volt is an equal opportunity employer.

Keywords: Volt Services Group, Santa Clara , Regulatory Affairs Representative-Oracle Implementation, Other , Santa Clara, California

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