Staff Engineer Regulatory Affairs

About the role

Staff Engineer Regulatory Affairs at Stryker. Lead regulatory support for New Product Introduction (NPI) and sustaining activities in designated APAC markets, including Hong Kong, Singapore, Macau, and Taiwan.

What you'll do

• Lead regulatory support for New Product Introduction (NPI) and sustaining activities in designated APAC markets, including Hong Kong, Singapore, Macau, and Taiwan
• Prepare, compile, review, and submit regulatory dossiers, registrations, renewals, amendments, and notifications in accordance with local regulatory requirements
• Assess the regulatory impact of product, labelling, manufacturing, supplier, specification, and design changes and determine required regulatory actions
• Maintain product registrations and licenses throughout the product lifecycle, ensuring continued compliance with applicable regulations and market requirements
• Coordinate with regional regulatory teams, distributors, and in-country representatives to support regulatory submissions and market access activities

What you need

• 5–7 yrs of experience
• Regulatory affairs
• Documentation
• Communication
• B.Tech or B.E. or M.Tech