Stryker

Regulatory Affairs & Quality Assurance Specialist (12 Months Contract)

Stryker  •  Hong Kong, HK / Taikoo Shing, HK (Hybrid)  •  2 hours ago
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Job Description

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.

Travel Percentage: 0%

Stryker

About Stryker

Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. More information is available at stryker.com and careers.stryker.com.

Facts:

● 2024 Sales: $22.6 billion

● Industry: Medical Instruments & Supplies

● Employees: 53,000 worldwide

● 40 years of sales growth leading up to 2020

● 44+ Manufacturing and R&D Locations Worldwide

● $1.5 billion spent on research and development in 2024

● ~14,200 patents owned globally in 2024

● Products sold in ~75 countries

● Fortune 500 Company

● 7 consecutive years as one of Fortune's World's Best Workplaces

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Industry
Manufacturing & Production
Company Size
10,000+ employees
Headquarters
Kalamazoo, MI
Year Founded
Unknown
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