Posted 1 week ago

Regulatory Affairs & Quality Assurance Specialist (12-Month Contract)

Stryker China Ltd Hong Kong, Taikoo Shing, 12 Taikoo Wan Road
Hybrid Full Time
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Job description

Work Flexibility: Hybrid Job Description We are seeking a RAQA Specialist to join our team on a 12-month contract, supporting Regulatory Affairs and Quality Assurance activities across the Hong Kong and Macao markets. The role involves supporting product registration and license maintenance activities, maintaining regulatory databases, coordinating with internal and external stakeholders, and ensuring compliance with applicable regulatory requirements. The successful candidate will work as part of a regional team and collaborate with cross-functional partners to support business and regulatory objectives. Subject to business needs, there may be opportunities for contract extension or conversion to a permanent position. 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 Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.