Regulatory Affairs Specialist

Designation: Engineer

Location: USA

Qualification: Bachelor’s Degree


  • Reviewing Design History Files, technical files and doing a gap assessment to find any
    discrepancies between the new and old regulations for the Chinese FDA and European
    Union Medical Device Regulations (EU MDR)
  • Preparing submissions to renew ISO 13485- Quality Management Certificate to BSI for
  • Reviewing and verifying Product Testing Reports (PTRs), product drawings, material
    specifications to ensure that they meet the current Chinese FDA regulatory requirements
    and resolving any found discrepancies.
  • Assisting in successful implementation of the European Medical Device Regulations as
    per the revised EU MDR 2017/245 to ensure compliance and timely documentation for
    regulatory filing.
  • Preparing for EU submissions as per the revised MDR guidelines and working on
    Technical files for Class I sterile, Class I non-sterile, Class I reusable, Class I measuring,
  • Class IIa, Class IIb and Class III medical devices to ensure timely submission of the
    technical file.
  • Revising and updating the Declaration of Conformity (DoCs) for respective technical
    files and design dossiers and ensuring that it represents all the current standards and
    regulatory requirements applicable to the respective medical device as per the revised EU
  • Supporting the review of product labeling for medical devices and assisting in
    maintaining the current labels as required by the new EU MDR.
  • Making technical files that are currently compliant with MDD 93/42/EEC in accordance
    with the new MDR (2017/245) by using the General Safety and Performance requirements(GSPR) and ensuring that all the changes required as per the new regulation
    are fulfilled technical files are submitted to BSI by the required timeframe.
  • Assisting in dossier preparations for product registration submission to Chinese FDA.

Bachelor’s degree: Regulatory Affairs for Drugs, Biologics, and Medical

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