Job Description :
Title: Regulatory Specialist

Location: Pleasanton, CA

Duration: Contract

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