Labeling Specialist, Regulatory Affairs
Website Olympus Corporation of the Americas
In order to be considered, applicants must apply at our career website: https://career4.successfactors.com/sfcareer/jobreqcareer?jobId=2520&company=olympuscorP
Support and participate in the creation, editing, processing, and translation of labels and IFUs. Ensure the regulatory compliance of labeling materials including labels and instructions for use (IFUs), and other materials.
Ensure compliance with UDI requirements. Support the completion of corrective actions and the addressing of internal and external audit findings. Provide support during third-party and regulatory audits.
* Develop, edit, review, and process changes to labeling materials to ensure that Gyrus ACMI is in compliance with all federal, state, and international labeling requirements. Labeling materials include labels and instructions for use (IFU).
* Provide input and advice for labeling matters including assessment of regulatory requirements, labeling procedure requirements, and labeling infrastructure.
* Carry out activities to ensure compliance with UDI requirements.
* Follow up resolution of internal audit findings and external audit findings through the Gyrus ACMI Corrective and Preventive Action program.
* Assist in responding to regulatory inspections by regulatory agencies.
* Support manufacturing, engineering, quality assurance, product development, and clinical affairs as required to ensure regulatory compliance.
* Assist with the development of quality system procedures as they relate to labeling.
* Bachelor’s Degree preferred, preferably in graphic design, packaging engineering, regulatory affairs, related life sciences field, or comparable experience in the Medical Device Industry (2 years preferred).
* Documented continuing education in regulatory affairs or RAC certification is a plus.
* Experience or knowledge of medical device labeling development (labels and/or IFUs).
* Must be able to occasionally travel to Olympus/OSTA facilities in the U.S.
* Graphic design and development experience is preferred.
* Knowledge of ISO 13485/QSR requirements is preferred.
* Knowledge of ISO 15223 requirements is preferred.
* Proficiency in Microsoft Office (Word, Excel or Access, PowerPoint) is preferred.
* Proficiency in Adobe Illustrator, InDesign, and/or Framemaker is preferred.
* Proficiency in labeling software systems (LabelView, Loftware, Prisym, Label, Robar, etc.) is a plus.
* Proficiency with thermal transfer label printers (Zebra, SATO,DataMax) is a plus.
* Other Considerations (travel/hours availability, etc.)
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