Regulatory Officer
Techno orbits
Employer Active
Posted 12 hrs ago
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
Main Duties
- Write, analyse, and edit technical documents to support SFDA regulatory submissions and compile submissions in a format consistent with applicable guidance documents.
- Maintain regulatory files. Maintain and update regulatory authorizations SOPQ AR mandate medical device licenses and CE dossiers for EU NRTL certifications etc. Assure that appropriate maintenance of registrations occurs including renewals device listings registrations supplements for changes and annual reports.
- Assist in preparing responses to regulatory authorities questions within assigned timelines.
- Review and maintain registration file for MDMA.
- Review and maintain registration file for Low-Risk.
- Review and maintain registration file for MDEL
- Review and maintain registration file for MDIL for each shipment when it applicable.
- Review and maintain registration file for AR License.
- Follow up and action for renewal of MDM MDNR MDEL and any other license with SFDA.
- Submitting application with SFDA :- MDMA MDNR AR MDEL & MDIL.
- Distribution Agreement : Review and commenting for new/renew distribution agreement.
Company Industry
- IT - Software Services
Department / Functional Area
- Administration
Keywords
- Regulatory Officer
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Techno orbits