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Regulatory Affairs Specialist
Basic Functions:
- Support in new product registrations, variations, and renewals for MP AP's products
Duties:
- Prepare documents for registration to countries
- Co-work with sales/marketing for providing documentation supports to countries
- Maintain registration dossier properly
- Support in updating CE technical documents annually
- Assist in Notified Board audit and review
- Ensure the registration database is updated and inform the relevant departments for any changes
- Monitor global regulations/standards actively
- Verify the labelling accurately per regulatory requirements
- Assist in internal/external audit
Requirements:
Ability to:
a. Understand how to review technical documents and provide feedbacks to R&D if there is any regulation update
b. Compile the registration documents correctly and efficiently
Knowledge of:
a. Regulations/standards for medical devices/In vitro diagnostics
b. Technical terminology used in the laboratory
Education: Basic Science Degree
Experience: 1-2 years in RA/QA or in medical device/IVD industries
Recommended Skills
- Audit
- Compliance
- Iso
- Legislation
- Surveillance
- Terminology
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