Annie

Annie

$25/hr
Biomedical Engineer with Master's Degree.
Reply rate:
-
Availability:
Hourly ($/hour)
Location:
Yerevan, Yerevan, Armenia
Experience:
10 years
About

Regulatory Affairs, Customer Support, Help Desk Specialist

Regulatory Affairs Specialist of Medical Devices in ClinChoice LLC, Armenia:

  • Submission and registration of medical devices in US, EU and ROW.
  • Actively collecting all necessary documents for medical devices registrations in international markets.
  • Working with the relevant cross functional teams to collect the required documents in order to meet local regulatory requirements.
  • Obtaining necessary legal documents (e.g. CFG, CFS, supporting documents from projects), including responding to queries and notifying the leadership of any Health Authority related questions.
  • Conducting regulatory assessments for US, EU and international, which may include Internal Letters- to-File.
  • Performing updates in the Global Unique Device Identification Database (GUDID).
  • Attending meetings and communicating with the project team as appropriate.
  • Communicating daily or weekly with the regulatory management team regarding project status and deliverables.
  • Conducting Status Review & weekly update meetings in collaboration with PM.
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