Regulatory Affairs & Quality Assurance Specialist (12-Month Contract)
Stryker is one of the
·Yesterday
- Location
- Taikoo Shing, 12 Taikoo Wan Road, Hong Kong
- Workplace
- Hybrid
- Type
- Contract
- Department
- IT
- Education
- Bachelor
- Source
- Workday
Description
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
