Regulatory Affairs & Quality Assurance Specialist (12 Months Contract)

Work Flexibility: Hybrid

As the healthcare landscape evolves in Hong Kong and Macao, we are hiring a RAQA Specialist on a 12 months contract to proactively register our products in Hong Kong and Macao. This role is part of a regional team covering Hong Kong and Macao markets and will offer you great learning opportunities if you are looking to further develop your career in RAQA. 

Subject to business needs, there is an opportunity for contract extension or conversion to a permanent position. 

What you will be doing:

• Maintain global and local databases used by Regulatory Affairs (RA), including but not limited to local database and tracker, tender database, global registration systems and ERP system.
• Provide RA support for quotations and tender exercises. 
• Prepare and compile dossiers for product registration, change submission/notifications, license renewals and manage other registration needs according to Company timeline and objectives.
• Assess the impact of product design change on license 
• Represent the RAQA function as a point of contact for all stakeholders, manage product complaints, commercial hold and field actions for Stryker Hong Kong. 
• Other relevant tasks as assigned. 

What You Will Need

Required Qualifications

• Bachelor's degree in Biomedical Engineering, Life Sciences, Pharmacy, Biotechnology, Nursing, Medical Science, or a related field.
• Recent graduates are encouraged to apply.
• Proficiency in Microsoft Office applications, including Excel, Word, and PowerPoint.
• Professional proficiency in English, Cantonese and Chinese.

Preferred Qualifications

• Internship, placement, or 1 year work experience in healthcare, medical devices, pharmaceuticals, biotechnology, or a related industry.
• Understanding of regulatory affairs, quality assurance, product registration, or compliance requirements.
• Experience maintaining databases, preparing documentation, or supporting administrative processes in a regulated environment.
• Familiarity with ERP systems or document management systems.

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