Labeling Specialist

Bioventus-posted 1 day ago
Full-time • Entry Level
Memphis, TN
251-500 employees
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Are you ready to work for a more active world? At Bioventus, our business depends on developing our people. We invest in you and challenge you to be the best. We value our colleagues for their different perspectives and individual contributions, and our leaders listen. Our success rests on working together to achieve shared goals and rewards. Join a diverse team of global colleagues driven to help patients resume and enjoy active lives. The Labeling Specialist is responsible for executing and maintaining accurate, compliant product labeling, artwork, and associated documentation across the Bioventus portfolio. This role supports the Senior Labeling Engineer in developing, updating, and controlling labeling content in alignment with global regulatory requirements (FDA, ISO, EU MDR), internal quality systems, and product lifecycle needs. The Labeling Specialist partners cross-functionally with Quality, Regulatory, Engineering, Supply Chain, and Marketing to ensure timely delivery of high-quality labeling materials.

  • Create, update, and maintain product labels, IFUs, package artwork, and labeling components according to approved specifications and regulatory requirements.
  • Support development and revisions of labeling content, ensuring accuracy, clarity, and compliance (UDI, symbols, warnings, language requirements, etc.).
  • Execute changes through document control and change management process (within relevant QMS systems).
  • Maintain labeling specifications and ensure correct version control across manufacturing and distribution sites.
  • Collaborate with Regulatory Affairs to incorporate required updates from global submissions, standards, and regulations.
  • Partner with Marketing to align branding updates and ensure consistency with approved messaging and claims.
  • Coordinate translation requests and manage multi-language labeling content, ensuring correct implementation.
  • Assist in root cause investigations related to labeling errors, deviations, or complaints; support CAPA activities as assigned.
  • Conduct labeling reviews during new product development and product sustaining engineering projects.
  • Work with Supply Chain and Operations to ensure correct label availability, proper printing, and implementation timing.
  • Check proofs, artwork, and printed materials from vendors for accuracy and quality.
  • Maintain 100% audit-ready documentation and support internal and external audits as needed.
  • Support the Senior Labeling Engineer with process improvements and standardization of labeling workflows, tools, and templates.
  • Other duties as assigned.
  • Bachelor’s degree or equivalent experience in Quality, Regulatory, Engineering, Life Sciences, Technical Communications, or related field.
  • 1–3 years experience in medical device, pharmaceuticals, or other regulated industry.
  • Knowledge of FDA 21 CFR Part 801/830, ISO 15223, ISO 20417, UDI regulations, and labeling standards.
  • Strong attention to detail and ability to manage multiple projects simultaneously.
  • Experience with document control, change control systems, or QMS tools.
  • Proficiency with Microsoft Office, sound decision making, innovative thinking, and excellent communications skills (written and verbal).
  • Proficient using MS Office and at least one engineering software product.
  • Proficient in Adobe Illustrator, Photoshop, InDesign, and Acrobat.
  • Familiarity with EU MDR, IVDR, and international labeling requirements, preferred
  • Proficient in Seagull Scientific BarTender preferred.
  • Proficiency in VBScript is a plus.
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