Regulatory Affairs Specialist, 12-month, CBD
2 weeks ago
Job Summary: To compile Dossiers for CoreDx products for submission into Hong Kong Medical Device Division and Macau's Ministry of Health, and other Regulatory Compliance related issues
Job Scope:
· To compile Technical Dossiers for Core-Dx products for submission into Hong Kong Medical Device Division and Macau's Ministry of Health.
· To carry out all related change to the existing registrations
· To answer queries from authorities on submitted Dossiers and Jobs
· To liaise with Global RA on technical files availability and obtain answers on authority's input requests
Requirements:
· Degree in Biomedical Sciences/ Bachelor of Science/ Medical Laboratory Technology/ Pharmaceutical
· At least 2 years working experience in a similar industry and/or hospital laboratory/ diagnostic medical /clinical trial laboratory and/or regulatory capacity, internship experience on regulatory and quality
· Scientific background with analytical mind and troubleshooting abilities
· Good communication skills/experiences working in a clinical laboratory
Additional Information:
· Salary – S$3.7K + 1-month bonus
· Contract duration: 12-month contract
· Commencement Date: Immediate
· Working days and hours: Monday to Friday, 9am to 6pm
· Location: Bugis
Tell employers what skills you haveTroubleshooting
Microsoft Office
FDA
Regulatory Compliance
Regulatory Affairs
ISO
Regulatory Strategy
Biomedical Engineering
Surveillance
Compliance
Medical Devices
Product Development
Regulatory Requirements
Life Sciences
Laboratory
Manufacturing
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