Regulatory Affairs Labeling Specialist

  • location: Carlsbad, CA (remote)
  • type: Contract
  • salary: $1 - $55 per hour

job description

Regulatory Affairs Labeling Specialist

job summary:
Randstad Technologies is seeking a Labeling Specialist for one of our top clients specializing in the healthcare and medical device industry. As a Regulatory Affairs Labeling Specialist, you will perform and/or oversee the activities needed to create and update

product labeling, from creating requirements, to translating the requirements into labeling, to releasing the labeling into production. You may also update labeling-related Quality System documents and, as needed, streamline and bring efficiency to the labeling process 
location: Carlsbad, California
job type: Contract
salary: $1 - 55 per hour
work hours: 8am to 5pm
education: Bachelors
 
responsibilities:
  • Create/coordinate the production of Adobe Illustrator artwork files for device and packaging labels, both purchased and printed inhouse
  • Create production artwork/support Production in development of Loftware production label artwork
  • Collaborate in a cross-functional environment to determine size and placement of labels
  • Work to develop label engineering drawings
  • Prepare engineering change orders to release label artwork and associated drawings
  • Contribute to label requirement specifications
  • Perform label verification activities as needed, including development of verification protocols, execution of verification, and development of verification reports
  • Interface with suppliers and contract manufacturers as needed to support label production
  • Team with technical writers to obtain translations of labels
  • Track label projects and report on progress to management
  • Develop other labeling-related documentation, including labeling plans and Quality System documents
 
qualifications:
  • Experience level:
  • Education: Bachelors
 
skills:
  • Regulatory Affairs / Compliance

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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