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.