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Quality Assurance/Regulatory Affairs

2 months ago

Akron, United States ComTec Information Systems Full time
Job DescriptionJob Description

Job Description

NetSuite Regulatory & Chemical Item Data Attribute Review & Cleanup:

Resource to assist in performing the review of NetSuite Item attribute data to either confirm or identify the below Regulatory & Chemical data attributes. Effort to be performed via regulatory analysis, review of labeling/claims, & supplier questionnaires. This effort will also require interaction with procurement & suppliers to obtain requested information, establish supplier agreements, and manage needed supplier product label updates.

  • Product Type by Country/Region (US, EU, Canada, Australia)
    • Options: Medical Device, OTC Drug, Cosmetic, Food, or Non-Regulated
  • Medical Device Classification by Country/Region (US, EU, Canada, Australia)
    • Options: Class I, II, III, IV
  • GDMN
  • Class II & Above Medical Device License/Registration #s (e.g. MDAL/MDEL or 510(k) #'s)
  • FDA Data:
    • Establishment/Registration #
    • Medical Device Product Code
    • Medical Device Listing #
    • 510(k) # if applicable
    • NDC # if applicable
    • UDI/GTIN
  • EU Data:
    • GDMN Codes
    • DOCs
    • SRN
  • Evidence of Medical Device Registration/DoCs by Country or Region (As applicable)
  • Label Samples
  • Chemical Compliance:
    • COSH
    • REACH
    • WEEE
    • RoHs
    • CRAM
    • PFAS
    • Prop 65
    • Latex
  • Sterility
  • Battery Compliance