Regulatory Affairs Labeling Specialist

Location: Irvine, California, United States
Salary: competitive
Job Type: Contract
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Regulatory Affairs Labeling Specialist

About the Company:

A medium-sized Class II medical device company, located in Irvine, CA, is making significant strides towards the production of medical equipment for COVID-19. They are currently seeking multiple contract labeling specialists to support the project.

About the Role:

The individual(s) in this role will report into the company's Regulatory Affairs Manager. The labeling specialist(s) will ensure that all medical device labeling regulations are met, and comply with US FDA regulations, EU MDD/MDR regulations, and others. The individual(s) will review technical communication documents to ensure compliance with global regulations, and interpret the intent of regulations to provide guidance to project teams and management. Individual(s) will create labeling artwork and author technical communication for Class II medical device labels.

Your skills and experience

  • 3-5 years minimum of medical device industry experience within regulatory affairs, labeling, or technical communication
  • Knowledgeable of US FDA, EU, and other international regulatory guidelines
  • Experience using Microsoft Suite, Adobe Acrobat InDesign, Illustrator
  • BA or BS in the life sciences or relevant

About You:

You are knowledgeable in the medical device field with specific knowledge pertaining to regulatory affairs, labeling, or technical communication. You have participated in labeling projects before and possess the technical knowledge needed to hit the ground running in a fast-paced project. You respond well to a challenge and enjoy collaborating with a team to meet a shared goal. You are local to OC/So Cal, and available to be 40/hours week, on-site once deemed safe to do so.

Sthree US is acting as an Employment Business in relation to this vacancy.

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