Spec Regulatory Labeling

Medline Industries LP

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Review packaging submissions for regulatory compliance
Research fda regulations for devices and otc drugs
Conduct internal audits of files and databases
** Medline Industries LP is seeking a Spec Regulatory Labeling professional to ensure compliance with state and federal regulations regarding product labeling. The role involves reviewing packaging submissions, researching regulatory changes, and training new staff, all within a collaborative environment aimed at continuous improvement. **

Job Summary

  • The role is responsible for aligning product labeling content with state and federal regulations under general supervision.
  • Candidates must evaluate supporting documentation for relevant regulatory authorities and research changes in device and OTC drug requirements.
  • The position involves conducting internal audits, maintaining department databases, and mentoring new employees on regulatory procedures.

Matching Summary

Match Score: 75

** Medline Industries LP is seeking a Spec Regulatory Labeling professional to ensure compliance with state and federal regulations regarding product labeling. The role involves reviewing packaging submissions, researching regulatory changes, and training new staff, all within a collaborative environment aimed at continuous improvement. **

Skills & Requirements

Must-have

  • Review packaging submissions for regulatory compliance
  • Research FDA regulations for devices and OTC drugs
  • Conduct internal audits of files and databases
  • Train employees on regulatory labeling requirements

Nice-to-have

  • Experience with Kaizen process improvement
  • Strong project management and critical thinking skills
  • Ability to influence cross-departmental change

Key Requirements

  • Bachelor's Degree in Science or related field
  • At least 2 years of experience in Quality or Regulatory Affairs
  • Knowledge of FDA product codes and Good Manufacturing Practices

Work Rights

Not specified

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