Labeling Specialist

Irvine, CA 92618

Employment Type: Contract to Hire Industry: Medical Device Job Number: 17712 Pay Rate: $20-$21/hr

Job Description

This Specialist will manage all medical device and package labeling in accordance with FDA Regulations, EUMDR, ISO requirements and Standard Company Operation Procedures. General Description and Duties: Key responsibilities:
  • Maintain Instructions for Use documents, product labels and packaging labels in compliance with regulatory standards as well as internal labeling requirements.
  • Work with multi-functional team (engineering, marketing, manufacturing, regulatory, legal) to facilitate completion of labeling and artwork assignments.
  • Manage and support UDI implementation.
  • Manage prepress activities necessary to prepare labeling artwork files for accurate output.
  • Partner with vendors for translation projects. Identify translation issues and determine resolutions.
  • Coordinate between print house and translation house.
  • Proofread labeling artworks to ensure content meets label specifications.
  • Support production team in labeling execution and labeling inventory management.
  • Manage update of online IFUs.
  • Provide input to Quality team for labeling SOPs.
  Projects and Other Duties:
  • Most work is highly independent and collaborative in nature.
  • Execute strategic initiatives related to labeling.
  • Responsible for training others in subjects related to product labeling.
  • Serve as a point person for project teams for labeling changes.
  Position Qualifications:
  • Bachelor’s degree in a technical field.
  • At least 3 years of work experience in medical device industry.
  • At least 1 year experience in managing or supporting labeling projects in medical device industry.
  • Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint).
  • Understanding of regulatory standards.
  • Clear and effective verbal and written communication skills.
  • Attention to detail and organizational skills.
  • Ability to work in a fast-paced team environment.
  • Technical writing skills preferred.
  • Project management experience preferred.
  • Working knowledge of Adobe InDesign preferred.
Minimum Education:
  • Bachelor’s degree in technical field.
Minimum Experience:
  • At least 1 year experience in managing or supporting labeling projects in medical device industry.
  Work Environment & Physical Demands of the Job: The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is regularly required to remain in a stationary position at least 50% of the time; operate computers and other office equipment; and communicate and exchange information. The employee is occasionally required to reach with hands and arms and to move within and between the buildings.  A computer terminal is used to access, input, and retrieve data. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision. Additional Important Information: Axonics may make reasonable accommodations to enable individuals with disabilities to perform the functions of this job, unless doing so would result in an undue hardship on Axonics.
This job description is subject to change and management reserves the right to assign or remove duties and responsibilities of this job at any time.

Meet Your Recruiter

Emily Munoz
Senior Recruiter

As Senior Recruiter, Emily works on finding qualified candidates for medical device and aerospace industry as well supporting our clients as account manager.  Emily focuses on finding the right people for her clients and the right fit for her candidates.  Emily graduated from California State Polytechnic University, Pomona with a degree in Hospitality Management, Prior to working as a recruiter, Emily worked managing coffee shops for over 10 years.  Emily uses her customer service skills and background to help people find their ideal work environment. 

During her off time, Emily enjoys cooking, baking and spending time with her husband, two sons and her dog Rosie.


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