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Regulatory Affairs Associate

San Jose, CA
Purpose
This position is responsible for providing Regulatory Affairs support in the design, development, and manufacture and post-market activities.   
Responsibilities
•   Assist with domestic and international regulatory submissions.
•   International device registration and preparation of device dossiers for approval and maintenance of commercial distribution
•   Assist with literature and label approval
•   Assist with worldwide adverse incident reporting (Vigilance/MDR reporting)
•   Assist with Quality Management System and regualtory audits of VitalConnect
•   Assure compliance with developing international and federal regulatory requirements and guidelines and with existing regulatory approvals
•   Interact with multi-function project teams and corporate partners
Education
  • Requires a Bachelor’s Degree
Experience
  • 2 years minimum experience in a medical device environment
Knowledge and Training
  • Working knowledge of regulations, standards and guidelines related to regulatory affairs
  • Ability to use word processing, spreadsheet programs, and email such as MS Office and Excel
 

 

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