Job Description

Work Flexibility: Hybrid

What You Will Do:

• Maintain global and local databases used by Regulatory Affairs (RA), including but not limited to local databases and trackers, tender databases, global registration systems, and ERP systems
• Provide RA support for quotations and tender exercises
• Prepare and compile dossiers for product registrations, change submissions/notifications, license renewals, and other regulatory requirements in accordance with company timelines and objectives
• Assess the regulatory impact of product design changes on existing licenses and registrations
• Represent the RAQA function as a key point of contact for stakeholders, and manage product complaints, commercial holds, and field actions for Stryker Hong Kong
• Perform other duties and responsibilities as assigned

What You Will Need:

Required Qualifications

• Bachelor's degree in Biomedical Engineering, Life Sciences, Pharmacy, Biotechnology, Nursing, Medical Science, or a related discipline
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint
• Professional working proficiency in English, Cantonese, and Chinese
• Strong organizational skills with attention to detail and accuracy
• Ability to manage multiple priorities and meet deadlines
• Effective communication skills and the ability to work collaboratively with cross-functional stakeholders

Preferred Qualifications

• Experience in healthcare, medical devices, pharmaceuticals, biotechnology, or another regulated industry through employment, internships, placements, or academic projects
• Knowledge of regulatory affairs, quality assurance, product registration, or compliance requirements
• Experience maintaining databases, preparing documentation, or supporting administrative processes
• Familiarity with ERP systems, document management systems, or similar business applications
• Analytical and problem-solving skills
• Ability to work independently while contributing effectively within a team environment
• Commitment to quality, compliance, and ethical business practices

Travel Percentage: None