Regulatory Affairs Specialist III
Singapore - Marsiling Update time: October 16,2019
Job Description
Job Title : Regulatory Affairs Specialist
Reports to : Regulatory Affairs Manager
Location : Singapore - Marsiling
Term : 12 months Fixed Term Contract
Job Description:
- Provide regulatory strategy for Southeast Asia (SEA).
- Ensure all new and existing products are registered within Southeast Asia (SEA), including initial registration, renewal, amendment, change notification, etc.
- Reporting MDR/Adverse Event/FSCA/Recall to regulatory authorities when necessary.
- Review labeling and promotional materials for regulatory compliance.
- Collaborating with global Regulatory Affairs colleagues for international product registrations.
- Develop and maintain regulatory intelligence of SEA regulations
- Other work that may be assigned by manager
Requirements:
- Bachelor's Degree in Biomedical Engineering or equivalent
- 5 years of experience in Regulatory Affairs in in-vitro diagnostic and/or medical device industry
- Experience in compilation and submission of Common Submission Dossier Template (CSDT)
- Experience in Animal Health (Veterinary diagnostics) product or food safety instrument is a plus
- Knowledge and experience in regulatory requirements: US FDA 21 CFR part 820, European Medical Device Directive/IVD Directive, ISO 13485.
- Self-initiator, Meticulous, detail-oriented, cross-functional working experience, strong communication skills.
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