- China - Beijing
Our client is an international company manufacturing and selling in specific “active” medical devices. For this client, we are looking for a Regulatory Manager.
Job location: Beijing
- VP Sales & Marketing for APAC,
- HQ’s RA manager
And working closely with the team at their Beijing office
Ensuring the compliance of our client’s current and new devices with the local rules and regulations of China by collaborating with internal (R&D, production, marketing) and external stakeholders.
1. CFDA relations and experience: Familiar with the officials is a benefit, and understanding their requirements for submissions, for timely approvals.
2. Regulations: In depth-understanding and application of CFDA and CQC regulations and the related regulatory process.
3. Technical expertise: Knowledge of process and methods and medical product area such as product specifications, product developments / expansions and product safety.
4. Understanding of the IEC and related GB standard for good communications with the BIU and CFDA or CQC testing lab’s engineers.
5. Excellent communications skill with internal and external customers, both in Chinese and English.
Duties and responsibilities include:
1. Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current and pending guidance, regulations, Agency or industry initiatives, etc.
2. Develop and take the ownership of China CFDA submissions
3. Support Key market RA team on global registrations
4. Establish active communications with regulatory agencies in China and monitor their progress.
5. Review and approve advertising, promotional items and labeling for regulatory compliance
6. Communicate application progress to internal stakeholders
7. Stay updated with worldwide colleagues regarding license renewals and updates
8. Maintain regulatory files and tracking databases as required
9. Manage administrative tasks of the company registered China entity (e.g., with bank, advocate, routine fees payment, etc.).
1. BSc in engineering discipline or equivalent education, experience, training.
2. At least 5 years regulatory experience in medical device industry, preferred in aesthetics or dermatology.
3. Experience in China local manufactured or local developed products will be a plus.
4. Strong understanding of China CFDA/NMPA and other major international regulations
5. Be able to manage multiple tasks and perform with accuracy and a high attention to detail.
6. Be able to forecast and report to head office the realistic timeline for submissions and achieving licenses.
7. Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
8. Proficient in English communication including reading, writing, speaking and listening.
9. Understand basic engineering terminology for being able to communicate effectively with the company and China lab engineers when technical information is required by China labs during their testing of company products.
Suitable candidates will be contacted within one month upon application.