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Regulatory Specialist
Ref No.: 18-40958
Location: Pleasanton, California
Start Date: 07/24/2018
Job title:  Regulatory Specialist
Duration Long term contract
Location Pleasanton CA


Job Description:
·         Responsible for providing a global regulatory assessment to determine impact of supplier transfer activities
·         Experience in medical devices which has mechanical & electrical components
·         Experience in various type of regulatory submissions, especially PMA (Pre-market Approval)
·         Experience in submission writing
·         Responsible to work with internal SME team (R&D, ME, QE, supply chain and RA management) to identify the deliverables needed for regulatory submission.
·         Reviewing design/V&V/risk assessment/validation activities to ensure it meets global regulatory requirements.
·         Follow relevant procedures to ensure compliance
·         Play the role of primary Regulatory point person