China Regulatory Affairs Specialist: Market Access

Smith & Nephew plc; Sha Tin; On-site; HKD 600,000 - 900,000; Full time

Job summary

Smith & Nephew plc is seeking a Regulatory Affairs Operations professional in Hong Kong to manage regulatory documentation for product registrations and renewals. You will coordinate with internal teams to gather technical, quality and clinical data, ensuring timely submissions and ongoing compliance.

The role supports regional regulatory activities, including filings for international markets and post-market surveillance, with a focus on maintaining licenses and databases across lifecycle

Qualifications

• Prepare, compile and review regulatory documentation for HK/Macau registrations.
• Support quality system records and lifecycle activities.
• Coordinate with internal teams to gather required regulatory materials.

Responsibilities

• Prepare and submit regulatory dossiers for assigned markets.
• Maintain regulatory licenses, approvals and product registration databases.
• Monitor submission status and support market access activities.

Skills

Regulatory documentation

Quality systems

Cross-functional collaboration

Job description

Smith & Nephew plc is seeking a Regulatory Affairs Operations professional in Hong Kong to manage regulatory documentation for product registrations and renewals. You will coordinate with internal teams to gather technical, quality and clinical data, ensuring timely submissions and ongoing compliance.

The role supports regional regulatory activities, including filings for international markets and post-market surveillance, with a focus on maintaining licenses and databases across lifecycle