PROCEPT BioRobotics

Senior Regulatory Affairs Labeling Specialist

PROCEPT BioRobotics

full-time

Posted on:

Location Type: Hybrid

Location: San Jose • California • 🇺🇸 United States

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Salary

💰 $117,000 - $138,000 per year

Job Level

Senior

About the role

  • Design graphic content for label artwork using design software, such as Adobe Illustrator, as well as dedicated labeling software, such as Bartender
  • Draft written content for product inserts, using desktop publishing software such as Adobe InDesign
  • Apply style guidelines and branding standards to new and modified product labeling
  • Verify that labeling complies with all applicable requirements
  • Create and revise label items within the company’s document control system, by drafting and releasing engineering change orders
  • Contribute to Labeling department process improvement initiatives
  • Represent the Labeling department on project teams by collecting potential labeling inputs from other departments; interpreting the impact that projects, such as design changes, will have on labeling content; and implementing necessary modifications to the product labeling.

Requirements

  • Bachelor’s degree, in scientific or engineering field preferred
  • Five (5)-plus years work experience in medical device field
  • Excellent written communication skills, especially with technical information.
  • Fluent in graphic design software and/or desktop publishing software
  • Precise, thorough and analytical
  • Proactive and adaptable to a fast-paced work environment, including managing multiple projects simultaneously
  • Advanced degree or credential in regulatory affairs preferred
  • Experience with e-labeling applications and/or content management system applications preferred.
Benefits
  • Full medical coverage
  • Wellness programs
  • On-site gym
  • 401(k) plan with employer match
  • Short-term and long-term disability coverage
  • Basic life insurance
  • Wellbeing benefits
  • Flexible or paid time off
  • Paid parental leave
  • Paid holidays
  • Many more!

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
graphic designlabel artwork designdesktop publishingengineering change orderse-labeling applicationscontent management systemsAdobe IllustratorAdobe InDesignlabeling compliancebranding standards
Soft skills
written communicationanalytical skillsattention to detailproactiveadaptabilityproject managementcollaborationprocess improvement
Certifications
Bachelor's degreeadvanced degree in regulatory affairs
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