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Regulatory Affairs & Quality Assurance Specialist (12 Months Contract) - job post

Stryker
3.8 out of 5 stars
12 Taikoo Wan Road, Taikoo Shing, Hong Kong Island
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Job details

Job type

  • Full-time

Location

12 Taikoo Wan Road, Taikoo Shing, Hong Kong Island

Full job description

Why join Stryker?

Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

Job description

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.


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.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
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