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

Stryker

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

full-timePosted: Aug 12, 2026Updated: Aug 28, 202612 Taikoo Wan Road, Taikoo Shing

Job Description

Work Flexibility: HybridJob DescriptionWe 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 systemsProvide RA support for quotations and tender exercisesPrepare and compile dossiers for product registrations, change submissions/notifications, license renewals, and other regulatory requirements in accordance with company timelines and objectivesAssess the regulatory impact of product design changes on existing licenses and registrationsRepresent the RAQA function as a key point of contact for stakeholders, and manage product complaints, commercial holds, and field actions for Stryker Hong KongPerform other duties and responsibilities as assignedWhat You Will Need:Required QualificationsBachelor's degree in Biomedical Engineering, Life Sciences, Pharmacy, Biotechnology, Nursing, Medical Science, or a related disciplineProficiency in Microsoft Office applications, including Excel, Word, and PowerPointProfessional working proficiency in English, Cantonese, and ChineseStrong organizational skills with attention to detail and accuracyAbility to manage multiple priorities and meet deadlinesEffective communication skills and the ability to work collaboratively with cross-functional stakeholdersPreferred QualificationsExperience in healthcare, medical devices, pharmaceuticals, biotechnology, or another regulated industry through employment, internships, placements, or academic projectsKnowledge of regulatory affairs, quality assurance, product registration, or compliance requirementsExperience maintaining databases, preparing documentation, or supporting administrative processesFamiliarity with ERP systems, document management systems, or similar business applicationsAnalytical and problem-solving skillsAbility to work independently while contributing effectively within a team environmentCommitment to quality, compliance, and ethical business practicesTravel Percentage: None

Locations

  • 12 Taikoo Wan Road, Taikoo Shing

Skills Required

  • Microsoft Office applicationsintermediate
  • Englishintermediate
  • healthcareintermediate
  • regulatory affairsintermediate
  • ERP systemsintermediate

Required Qualifications

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

Preferred Qualifications

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

Responsibilities

  • 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

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