Regulatory Specialist
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Regulatory Specialist
Ref No.: 18-28205
Location: Pleasanton, California
Position Type:Contract
Start Date: 04/24/2018
Responsible for providing a global regulatory assessment to determine impact of supplier transfer activities
  • Responsible to work with internal SME team (R&D, ME, QE, supply chain and RA management) to identify the deliverables needed for regulatory submission.
  • Tasks include:
    • reviewing design/V&V/risk assessment/validation activities to ensure it meets global regulatory requirements.
    • participate in documentation creation for receiving inspection and acceptance
    • support verification and validation activities, collaborate with Ops QE to align on needs
    • support manufacturing transfer internally by working with Operations
  • Follow relevant procedures to ensure compliance
  • Play the role of primary Regulatory point person