Reports to: Manager, Regulatory Affairs, SEA & SA

Department: Laboratory Products Division

Position Summary:

The individual will be responsible for executing regulatory strategy, providing regulatory guidance and support to cross functional teams across the Laboratory Products Division for strategic planning, design and development, and post-market surveillance and compliance activities.

Key Objectives of the role:

• Provide regulatory strategy for the South East Asia and Taiwan territories (SEAT).
• Ensure all new and existing products are registered within SEAT, 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.
• Partner with Commercial, Product Management (PMs), collaborate with global Regulatory Affairs colleagues and other cross-functional team for ensuring the regional product registrations in a timely manner
• Ensure the registration records filed and maintained properly.
• Develop and maintain regulatory intelligence of SEAT regulations
• Other work that may be assigned by manager

Minimum Qualifications and Experience:

• 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)
• 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.