Senior Regulatory Affairs Specialist

GN Hearing
Shanghai - China
Published: July 18, 2018
1. Be responsible for homologation sample inspection and communication with CFDA.
2. Optimize quality system of ISO 13485:2016.
3. Keep contact with inspection institute, complete homologation sample inspection work independently.
4. Be proficient in communication with provincial and city FDA, handle problem on market surveillance actively
5. Internal quality consciousness and knowledge training
6. Co-work with other departments, improve quality system and solve the related problem issue.
7. Technical document translation (English)
8. Handle/ archive quality related documents and record
9. Complete other tasks from manager
10. Support to accept audit from Corporate, DQS and CFDA
11. Support to communicate with CFDA

Qualification & competence requirements:
1. Medical device, biomedical engineering, mechanical engineering, electronic engineering, bioengineering, Chemical, Ecsomatics and so on. Associate degree and above.
2. At least two years relevant work experience
3. Master communication skills and be proficient in communication. Experience in collaboration and communication with related department internally. Experience in co-work with inspection institute and communication with CFDA is preferred
4. Be familiar with China medical device inspection standard and related regulation
5. Experience in quality knowledge training
6. Fluent English ( reading and writing )

For the purpose of processing your job application, GN will process your personal data. We encourage you not to provide us with sensitive information (e.g. racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, health information, or sexual orientation) about yourself. Your application will be transferred to the local GN office posting this job. For information about how GN processes your personal data, please read our » privacy policy