FONG'S ENGINEERING AND MANUFACTURING PTE LTD is seeking a Senior Regulatory Specialist to guide product development teams through regulatory strategy, ensuring compliance with international regulations for medical devices. The role focuses on preparing regulatory submissions, maintaining compliance throughout the product lifecycle, and liaising with global regulatory authorities
Job Summary
Provide independent regulatory strategy and guidance to product development teams to enable timely and compliant product launches.
Prepare, submit, and maintain premarket regulatory filings including U.S. FDA 510(k) submissions and EU Technical Files for Class I, IIa, and III medical devices.
Manage Medical Device Reporting and Vigilance reporting while collaborating on field safety corrective actions and product recalls.
Matching Summary
Match Score: 85
FONG'S ENGINEERING AND MANUFACTURING PTE LTD is seeking a Senior Regulatory Specialist to guide product development teams through regulatory strategy, ensuring compliance with international regulations for medical devices. The role focuses on preparing regulatory submissions, maintaining compliance throughout the product lifecycle, and liaising with global regulatory authorities.
Skills & Requirements
Must-have
U.S. FDA 510(k) submissions experience
EU MDR Technical Files preparation
Global medical device licensing knowledge
Vigilance reporting and FSCA management
Regulatory impact and gap analysis
Nice-to-have
Cross-functional stakeholder collaboration
Strategic planning for product launches
Database management for registrations
Post-market maintenance support
Key Requirements
Knowledge of U.S. FDA regulations and policies
Understanding of EU Medical Device Regulation (MDR)
Experience with global medical device registration