China Regulatory Affairs Specialist

HKG - Smith & Nephew Limited; 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

Regulatory Affairs Operations

Prepare, compile, review, and submit regulatory documentation for product registrations, renewals, amendments, notifications, and other lifecycle management activities in Hong Kong and Macau. Coordinate with internal stakeholders to obtain required technical, quality, clinical, and regulatory documentation to support submissions. Maintain regulatory licenses, approvals, certificates, and product registration databases to ensure continued compliance. Monitor approval status and follow up on regulatory submissions to support timely market access. Support regulatory assessments for product changes, labeling updates, manufacturing changes, and other regulatory impact evaluations.

Quality Assurance Activities

Support complaint handling activities in accordance with company procedures and applicable regulatory requirements. Assist with complaint documentation, investigation follow-up, trending, and record maintenance. Support post-market surveillance and vigilance activities where applicable. Maintain quality records and documentation in compliance with Quality Management System requirements. Assist with field actions, recalls, advisory notices, and other quality-related activities as required.

Regional Regulatory Support

Prepare and submit regulatory dossiers for assigned international markets. Coordinate with distributors, authorized representatives, and internal stakeholders to support registration and maintenance activities. Support responses to regulatory authority questions and requests for additional information. Maintain regulatory records and approval status tracking for assigned markets. Participate in new product launch and market expansion projects from a regulatory perspective.

Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer. Smith+ Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+ Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.