Identify, check, and assess product regulatory status (medical devices, poisons, hazardous substances).
Maintain medical device certificates/licenses and Letters of Authorization files.
Assist in checking local labeling implementation.
Involvement in regulatory process improvements.
Involvement in regulatory database management and maintenance.
Assist the team with other ad-hoc regulatory matters.
Conoscenze
Regulatory compliance
MSDS translation
Poison identification
Documentation management
Inter-departmental coordination
Formazione
Medical Bio-science / Biomedical Science / Biotechnology
Strumenti
Microsoft Word
Microsoft Excel
PowerPoint
Descrizione del lavoro
Salary Range < MYR 2,000
City Bandar Sri Damansara
Country Malaysia
Job Description
MSDS compilation for import clearance and poison item identification
MSDS translation intoBahasa Malaysia, in line with recent mandatory requirements byDOSHfor all Health Institutions (Private & Government)
Poisons identification housekeeping (Scheduled Poisons under the Poisons Act)
Inter-departmental supply chain housekeeping support
Identify, check, and assess product regulatory status according to regulatory requirements (medical devices, poisons, hazardous substances & flammables)
Medical device certificates/licenses and Letters of Authorization files upkeep and re-organization
Assist in checking product local labeling implementation
Involvement in regulatory process improvements
Involvement in regulatory database management and maintenance
Assist the team with other ad-hoc regulatory matters
Requirements
Background from Medical Bio-science, Biomedical Science, Biotechnology.
Detail oriented.
Organized, good documentation practice.
Basic ability to use Microsoft Word, Excels, Power Point.
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