Job Details

  • Title: Regulatory Affairs Associate
  • Code: RCI-5467
  • Location: Santa Clara California (CA) 95054
  • Posted Date: 09/29/2020
  • Duration: 12 Months
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  Job Description

West Coast based (Remote, but near Temecula, Santa Clara, Sylmar or Minnesota, Pacific Time Zone shift)

Regulatory Affairs Associate - Regulatory Operations

1 year assignment

Hours Monday-Friday • 8am-5pm

  • Site is Santa Clara Responsibilities: Execution of global product release authorizations following verification of regulatory approval and commercial alignment in activities.
  • Minimum 2 years’ Experience
  • Daily support of product releases allowing shipment of product to achieve departmental and organizational objectives.
  • Have a full working knowledge of the product release process including country regulatory and language requirements.
  • Provide support for Product and Country Experts in the set-up for release of new and modified products globally.
  • Acts as a regulatory representative for review and analysis of product release challenges, providing guidance and direction on regulatory compliance.
  • Review and evaluates customer service requests, maintaining a high level of service and follow through on all communications.
  • Systems knowledge such as SAP and Windchill is an advantage for creating releases

 

Quality background

Ability to work independently