TITLE: Regulatory Affairs Coordinator (China)
DEPARTMENT: Regulatory Affairs
REPORTS TO: Regulatory Affairs Project Manager
Biocomposites continues to experience dramatic growth, realising our mission to increase the number of patients we can help, by extending our market coverage in new specialities and new geographies.
We are continuing to grow in international regions including China, and now have an exciting opportunity for a Chinese speaker to join our growing teams here in the UK.
- Prepare and submit documents for registering and maintaining the Company’s site and product registrations in accordance with the medical device requirements in China and other APAC territories, as required.
- Communicate with and coordinate with internal and external stakeholders to plan, facilitate and submit product applications and to maintain products on market in China (and other APAC territories as required).
- Translate a variety of documents from internal and external stakeholders including technical documents, regulations, labels and application forms from Chinese to English and from English to Chinese, as required.
- Coordinate the impact of design changes on regulatory compliance and maintenance of product registrations in China, and other APAC territories, as required.
- Coordinate information systems to track registration status and renewal dates for products and regulatory documents.
- Maintain awareness and support colleagues regarding regulatory status of products in China.
- Create and maintain regulatory procedures, as required.
- Participate in internal and external audits.
- Provide general support for activities falling under the remit of the Regulatory Affairs Project Manager.
- Bachelor’s Degree in a life science discipline or equivalent.
- Native Chinese speaker.
- Fully proficient in both Chinese and English (written and oral).
- Strong written and verbal communication skills, with ability to convey matters clearly in both English and Chinese.
- Ability to translate technical text from Chinese to English, and from English to Chinese.
- Proficient in the use of Microsoft Office.
- Exceptional teamworking skills.
- Enthusiastic and eager to learn, motivated to develop a career within Regulatory/Medical Devices.
- Ability to handle communications.
- Ability to work under pressure, highly organized with an ability to multi task.
- Ability to coordinate multiple projects.
- Flexibility to work across different time zones with stakeholders in the UK and China, when required.
- Commutable to the office and able to work Monday to Friday, 8am-4pm or 9am-5pm.
- Right to work in the UK.
- Training or qualification in medical devices as well as any experience working within medical devices is desirable.
- Knowledge of ISO 13485.
- Knowledge of electronic document management systems.
- Understanding of medical device regulatory requirements in China.
Keele Head Office, Monday – Friday, 9.00 – 5.00, 35 hours per week
To apply please send your CV and cover letter stating the position you wish to apply for to contact: firstname.lastname@example.org