Regulatory Affairs Executive

Salary :

$2,500 - 3,500 monthly

Company : BIOPTIMAL INTERNATIONAL PTE. LTD.

Job Type : Full Time

14 Kaki Bukit View 415950

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Job Description - Regulatory Affairs Executive

Manage and handle the registration, renewal, change notification and local notification activities of worldwide markets until completion, except Europe / EEA / EU and MDSAP countries. Additional countries/territories may be added if new markets are opened for registration. 
Manage the application of Free Sales Certificate (FSC) and/or Certificate to Foreign Government (CFG) of the assigned markets for registration and renewal activities. 
Manage and coordinate the external apostille and legalization process of documents needed for registration, renewal, change notification and for other purposes. 
Manage the documentation of Post-market Surveillance Report (PMSR) and Periodic Safety Update Report (PSUR) of Bioptimal’s products according to frequencies in the PMS Plans. 
Provides internal audit, customer audit and certification/surveillance audit support according to the scope and frequency in the Audit Agenda/Plan. 
Maintains the documentation and compliance of the Essential Requirements (ER) documents and dossiers of Bioptimal’s MDD legacy devices. 
Maintains the documentation and compliance of Regulatory Affairs (RA) procedures, work instructions and other forms of documentation according to SAC/EN ISO 13485, MDSAP, 21 CFR Part 820 QSR and MDD/MDR requirements. 
Provides support for the MDR Technical Documentations including the creation of MDR technical reports.
Provides support on ad hoc tasks as may be assigned by the superior from time to time

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About the Company

BIOPTIMAL INTERNATIONAL PTE. LTD.

BIOPTIMAL INTERNATIONAL PTE LTD, a publicly-traded, multi-national corporation headquartered in Singapore is seeking highly-motivated individuals to join our dynamic team to continually develop, manufacture and commercialize innovative medical devices used in interventional cardiology and critical c...

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