Medical Device Labeling Analyst

Company: Comrise
Location: San Jose
Posted on: June 25, 2022

Job Description:

Overview***Remote Position***

• As a member of the Technical Publications team, you will review and update medical device labels for EU MDR and BREXIT projects.
• Manage barcode grading processes and systems as related to product labeling. Review content to ensure that labeling artwork and proofs meet company and regulatory requirements.
• Collaborate with product subject matter experts to gather and assess labeling content.
• Execute label formats and compile content using specialized software.
• This role requires a self-starter that is comfortable working with minimal supervision and learning/using new computer systems.
• They are extremely detail-oriented and have excellent organization and communication skills.
  Responsibilities--- Reviews and updates medical device labels for the EU MDR project.--- Performs label print testing, barcode grading, scanning, equipment set up, printer alignment, and other duties as needed.--- Ensures the accuracy and consistency of labeling, timeliness of changes, and overall approval of label.--- Collaborates with other EU MDR team members, Technical Writers, Labeling Specialists, SMEs, and Package Engineers to ensure labels are updated to the latest EU MDR standards.--- Creates and supports the development of label data, formats, families, and final product labels in Prisym (GLS).--- Follows all department processes and procedures to coordinate/execute labeling deliverables. --- Updates project manager on task-related schedules and identifies any blockers or issues that arise.--- Self-starter that is comfortable working with minimal supervision and learning/using new computer systems and programs.
  Qualifications:--- Minimum of 2 years of experience in creating/editing/printing labels.--- BA/BS Degree in Packaging, Graphic Design, Marketing, Software Engineering, Project Management, or related field.--- Experience working with InDesign, Prisym, Adobe Illustrator, Photoshop, and/or other labeling/graphic design programs.--- Experience in regulated industries (Medical Device, BIOTECH, Pharma, Aerospace).--- Experience with PLM, CMS, and QMS (e.g., Agile PLM).--- Knowledge of US and international medical device regulations and standards, especially those related to labeling (FDA, EU MDR, BREXIT).--- Experience working with cross-functional teams.--- Extremely detail-oriented.--- Excellent time management and communication skills.

Keywords: Comrise, San Jose , Medical Device Labeling Analyst, Professions , San Jose, California