Work Flexibility: Hybrid
What you will do-
· Lead regulatory support for Current 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.
· Monitor regulatory commitments, submission timelines, approval status, and renewal requirements to ensure uninterrupted product availability.
· Review technical documentation, product information, labelling,



and other supporting records for completeness, accuracy, and regulatory compliance.
· Support post-market regulatory activities, including field actions, vigilance-related submissions, product updates, and compliance requests as required.
· Maintain regulatory records, databases, and document repositories in accordance with internal procedures and document control requirements.
· Track changing regulatory requirements within assigned markets and assess the impact on existing products and planned product launches.
· Collaborate with Quality, R&D;, Product Engineering, Operations, Marketing, and Supply Chain teams to obtain required documentation and support regulatory deliverables.
· Independently manage multiple projects and priorities while delivering high-quality regulatory outputs within established timelines.
· Identify opportunities for process improvements, standardization, and efficiency enhancement across APAC regulatory a

📌 Senior Regulatory Specialist (Bengaluru)
🏢 Stryker
📍 Bengaluru