Job Description

Duties & Responsibilities:

  • Support the APAC regulatory team managing international and domestic filings/registrations, including drafting and compiling of technical files, tender request submission and any audit finding responses.
  • Communicate with headquarter regulatory team on local regulation changes with impact assessment.
  • Assist in communications with global regulatory representatives to assist in filings and responses to inquiries from health authorities.
  • Assist in maintaining product listings and establishment registrations with India regulatory authorities.
  • Familiar with BIS requirements and supporting import/exports for medical devices.
  • Assist in maintaining regulatory databases and summary reports to support management efforts to track and trend filing and registration requirements.
  • Maintain up-to-date knowledge on international and domestic regulatory requirements.
  • Provide regulatory support to ...

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