Regulatory Affairs & Quality Assurance Specialist (12-Month Contract)
发布于 大约 3 小时前普通员工/个人贡献者
AI 估算 · 25k–35k
香港医疗行业法规岗位，跨国企业合同制，薪资水平较高，需具备三语能力。
职位详情
关于这个职位
This is a 12-month contract role at Stryker, supporting Regulatory Affairs and Quality Assurance for the Hong Kong and Macao markets. You will manage product registrations, maintain regulatory databases, and coordinate with cross-functional teams. The role offers potential for contract extension or conversion to a permanent position.
最低要求
Bachelor's degree in Biomedical Engineering, Life Sciences, Pharmacy, Biotechnology, Nursing, Medical Science, or a related discipline
工作职责
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
优先资格
Experience in healthcare, medical devices, pharmaceuticals, biotechnology, or another regulated industry through employment, internships, placements, or academic projects
AI 洞察
优缺点分析
优点
- Work in a leading global medical technology company with a strong reputation.
- Gain hands-on experience in regulatory affairs and quality assurance.
- Exposure to the Hong Kong and Macao healthcare markets.
- Opportunity for contract extension or permanency.
- -month contract may offer limited job security initially.
- Requires proficiency in three languages, which may be challenging.
- Regulatory work demands high attention to detail and adherence to strict timelines.
- This role is suitable for recent graduates or early-career professionals in life sciences or biomedical engineering who are interested in regulatory affairs and quality assurance within the medical device industry.
缺点 / 挑战
暂无明显挑战项
角色解读
- Potential to convert to a permanent position after the 12-month contract.
- Opportunity to specialize in regulatory affairs for medical devices, a growing field.
- Possible career progression to senior RAQA roles or regional positions.
- Support product registration and license maintenance for medical devices in Hong Kong and Macao.
- Maintain regulatory databases and trackers, ensuring accurate record-keeping.
- Coordinate with internal and external stakeholders on regulatory and quality matters.
- Manage product complaints, commercial holds, and field actions.
- Knowledge of regulatory affairs and quality assurance principles.
- Proficiency in Microsoft Office and database management.
- Strong organizational, communication, and language skills (English, Cantonese, Chinese).
- Attention to detail and ability to handle multiple priorities.
申请策略
- Tailor your resume to highlight relevant regulatory and QA experiences.
- Show enthusiasm for the medical device industry and the opportunity to contribute to patient safety.
- Highlight any academic or internship experience in healthcare, medical devices, or regulated industries.
- Emphasize your knowledge of regulatory submissions, quality systems, or compliance.
- Showcase your database management and documentation skills.
- Mention your language proficiency in English, Cantonese, and Chinese.
- Familiarize yourself with medical device regulations (e.g., FDA, EU MDR, local Hong Kong requirements).
- Develop your Microsoft Excel and database management skills.
面试指南
- Use the STAR method (Situation, Task, Action, Result) for behavioral questions.
- For technical questions, demonstrate your understanding of regulatory processes and quality standards.
- Show your cross-cultural communication skills by highlighting experiences working with diverse teams.
- Why are you interested in regulatory affairs and quality assurance in the medical device industry?
- Describe a time when you had to manage multiple tasks under tight deadlines.
- How do you ensure accuracy and attention to detail in your work?
- What do you know about Stryker and its products?
- Explain how you would handle a product complaint.
职位点评
A regulatory affairs and QA contract role at a global medical device company, offering meaningful work and growth potential, but requiring on-site presence and a contract commitment.
从薪资福利、成长空间、工作节奏和岗位方向综合评估，方便横向比较。
薪资福利
The salary is competitive for the Hong Kong market, but the contract nature may reduce stability.
成长发展
The role offers growth potential through contract extension or permanent conversion, and exposure to regulatory expertise.
工作生活
The role requires on-site work in Hong Kong; no explicit work-life balance signals.
使命价值
Working in medical devices contributes to healthcare, providing a sense of purpose.