Regulatory - Expert in Santa Clara, CA at Volt

Date Posted: 7/28/2020

Job Snapshot

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 and/or 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 Master's 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.