Regulatory Affairs Executive

Công Ty CP Dược Phẩm Olympus

380

Hạn nộp hồ sơ :

01/01/2021

THÔNG TIN

VIỆC LÀM CÙNG CÔNG TY

CÔNG TY

MÔ TẢ CÔNG VIỆC

Main responsibilities:
- Perform product registration activities including drafting, reviewing, compiling, maintaining all necessary registration documentation for submissions according to local regulations. Ensure submissions are executed, monitored and accomplished for market clearance in a timely manner.
- Assure to maintain the validity of import licenses/ circular registration number for current medical devices.
- Register for new launching products as request from MKT Dept as timely manner.
- Monitor changes in the global regulatory framework to facilitate ongoing registration activity.
- Update the local regulation to related department.
- Handle recalls, field safety corrective actions (FSCA), quality products from customers' complaint. Report to MoH and M-BCs / OSP if any PAE, AE happens in Vietnam
- Manage various RA databases and documentation to ensure information is accurate and up to date.
- Work collaboratively with cross-functional team to ensure regulatory compliance and market continuity.
- Support RA Manager in formulation of regulatory project and drive RA operational excellence.
- Communicate with RA Department of Olympus Singapore and RA Department of Manufacturers
- Ensure updates of proper documentation as requested by Sales/MKT/SCM and provide administrative support to departments

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YÊU CẦU CÔNG VIỆC

- University Degree – Female under 30 preferred.
- Knowledge in Regulatory affairs on medical devices.
- Challenges analysis skill; Communication skill.
- Well spoken / written English.
- Hardworking, honest.

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QUYỀN LỢI

- Monthly gasoline allowance and telephone allowance.
- Health and accident Insurance as well as compulsory insurance scheme.
- Team-building activities, events.

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