Staff Labeling Specialist (Remote) - Military Veterans

Who we want:

• Problem solvers: Curious-minded achievers who resolve complex problems where precedent may not have previously existed
• Articulate communicators: Individuals with a natural ability to communicate complex concepts into easily understandable ideas both verbally and visually
• Relationship builders: Team players who collaborate and drive consensus with internal stakeholders to create powerful outcomes.

What you will do:

• Lead and strategize on new product labels for medical devices from concept to completion
• Maintain medical device product labels in compliance with global regulations and standards, including FDA, EU MDR, and others.
• Collaborate with cross-functional teams, including R&D, Regulatory Affairs, Quality Assurance, and Marketing, to ensure accurate and timely product label updates
• Mentor and train junior labeling specialists on best practices and regulatory requirements
• Establish and drive deadlines to meet project deliverables
• Review and approve product label artwork, ensuring alignment with regulatory requirements and company standards
• Stay current with product label regulations and industry trends to provide guidance and recommendations to the organization
• Assist with writing and maintaining work instructions regarding the device label process and procedures
• Participate in audits and inspections related to product label processes and documentation.
• Assist with the design and maintenance of product drawings.

What you need:

Required:

• Bachelor's degree in Engineering, Graphic Design, Life Sciences, Regulatory Affairs, or related discipline
• 4+ years of experience in designing and updating product labels for medical devices
• Knowledge and understanding of domestic and global regulations and standards. (Code of Federal Regulations governing medical device labeling (e.g., FDA, EU MDR).)
• Experience with Adobe Creative Suite/Cloud, Creo, CAD, Prisym, Jira, XML, or Windchill

Preferred

• Project management experience

$75,300.00 - $156,900.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.