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Regulatory Affairs Specialist, 12-month, CBD

1 week ago

Singapore Manpower Staffing Services (S) Pte Ltd - Head Office Full time

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 changes 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, including internship experience on regulatory and quality.
Scientific background with analytical mind and troubleshooting abilities.
Good communication skills and experience 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.
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