Quality - China - Kunshan
To support the business development, we are looking for an experienced Regulatory Manager in China now.
The position is based in Kunshan or Shanghai.
- Be responsible for all regulatory affairs in China.
- Be responsible for products registration at CFDA, including document preparation, testing, submission and technical review, query answer etc., to secure license in a good time manner.
- Manage labelling, leaflets, and liaison all external and internal stakeholders.
- Provide prompt regulatory support within greater China.
- Maintain regulatory knowledge, standards, documents, and apply appropriate implementation strategies.
- Bachelor’s degree with major in medical science or related field.
- At least 10 years' experience on active medical device registration, and experience from MNC will be a plus.
- Independent, and details focused.
- Excellent Written English skills, and good oral English will be a plus.
- Good communication skills and team player.