Senior Labeling Specialist

Quality        ·       Irvine, CA       ·       Full time

Job Title: Senior Labeling Specialist
FLSA: Salaried Exempt
Department: Quality
Reports To: Director, Project Management
To apply, e-mail your resume to careers@axonics.com

Job Responsibilities:

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.

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