Regulatory Affairs & Quality Assurance Specialist (12 Months Contract)
发布于 大约 2 小时前普通员工/个人贡献者
AI 估算 · 25k–40k
Contract RAQA role in Hong Kong, specialized skills but limited tenure.
职位详情
关于这个职位
This role involves managing product registration and quality assurance for the Hong Kong and Macao markets. You will maintain regulatory databases, prepare registration dossiers, and support tender exercises. It offers learning opportunities for recent graduates interested in a career in RAQA within a multinational medical device company.
最低要求
Bachelor's degree in Biomedical Engineering, Life Sciences, Pharmacy, Biotechnology, Nursing, Medical Science, or a related field.
工作职责
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.
优先资格
Internship, placement, or 1 year work experience in healthcare, medical devices, pharmaceuticals, biotechnology, or a related industry.
AI 洞察
优缺点分析
优点
- Gain hands-on experience in regulatory affairs at a global medical device leader.
- Work in a regional team covering Hong Kong and Macao, with learning opportunities.
- Contract extension or conversion potential based on performance.
- Develop expertise in product registration and compliance.
- -month contract may lack long-term stability.
- Requires proficiency in multiple languages (Cantonese, English, Chinese).
- Workload may involve managing multiple databases and deadlines.
- Recent graduates in life sciences or biomedical fields seeking entry into regulatory affairs, or experienced professionals looking for a contract role in a multinational company.
缺点 / 挑战
暂无明显挑战项
角色解读
- Advance to Senior RAQA Specialist or Regulatory Affairs Manager.
- Transition into broader quality assurance or compliance roles.
- Opportunity to convert to permanent position after contract.
- Manage global and local regulatory databases and trackers.
- Prepare and submit dossiers for product registration and license renewals.
- Support tender exercises and quotations with regulatory documentation.
- Act as point of contact for stakeholders on quality and regulatory matters.
- Knowledge of regulatory affairs and quality assurance in medical devices.
- Proficiency in Microsoft Office and database management.
- Fluency in English, Cantonese, and Chinese.
- Attention to detail and ability to manage multiple submissions.
申请策略
- Tailor your cover letter to express interest in regulatory affairs and willingness to learn.
- Demonstrate attention to detail and organizational skills in your application.
- Emphasize any academic or internship experience in healthcare, medical devices, or pharmaceuticals.
- Showcase database management skills and proficiency in Microsoft Office.
- Highlight language abilities in English, Cantonese, and Chinese.
- Mention familiarity with regulatory processes or ERP systems if applicable.
- Familiarize yourself with Hong Kong and Macao medical device registration requirements.
- Practice using ERP systems or document management software.
面试指南
- Use the STAR method (Situation, Task, Action, Result) for behavioral questions.
- For technical questions, explain your thought process and reference relevant standards.
- Show enthusiasm for the role and willingness to learn on the job.
- What is your understanding of the regulatory process for medical devices in Hong Kong?
- Describe a time you managed multiple databases or tracked complex information.
- How do you ensure accuracy when preparing documentation?
- How would you handle a product complaint that requires regulatory action?
- Why are you interested in a contract role in regulatory affairs?
职位点评
Contract RAQA role at Stryker Hong Kong, offering regulatory experience and learning opportunities, with average lifestyle fit and limited compensation certainty.
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 role is a 12-month contract with no disclosed salary range, offering limited compensation certainty. However, Stryker is a multinational, benefits may be included but not specified.
成长发展
The role offers learning opportunities and potential for contract extension, but it is not a technical role and career advancement is not explicitly outlined beyond conversion to permanent.
工作生活
Work location is in Taikoo Shing, Hong Kong, likely an office environment. No mention of remote work or flexibility, and overtime is not addressed.
使命价值
Working in medical device regulatory affairs contributes to patient safety and healthcare quality. The industry is stable and the role has positive social impact.