Registration Specialist
8-14k/*13
最低学历：
本科
招聘人数：
1
经验要求：
1年以内
工作地区：
浙江省杭州市滨江区
Job responsibilities:
1. Assist the supervisor in the domestic registration of the company's medical devices;
2. Assist in drafting product standards, follow-up testing, registration testing, clinical trials, etc. in accordance with the requirements of relevant laws, regulations and standards;
3. Assist in the preparation and management of technical documents of the company's products, formulate clinical research plans, and coordinate relevant resources for clinical trial research;
4. Contact and communicate with the State Food and Drug Administration and other departments to ensure the smooth submission, review and approval of each registration application, track the product registration process in real time, and ensure timely certification;
5. Keep close contact with inspection, testing and certification institutions, establish good relations, receive and accompany auditors to carry out relevant work, and ensure the smooth implementation of product registration inspection and quality standard review;
6. Understand and study the laws and regulations of new product certification and registration at home and abroad, and provide advice on new product registration or certification strategies.
Job requirements:
1. Bachelor degree or above in biology, chemistry, pharmacy, medicine and other related majors;
2. Familiar with national laws, regulations and national and industrial standards related to medical devices; Be familiar with the registration process of medical devices, complete the preparation of product registration standards, preparation of registration documents, contact with product testing and other matters;
3. More than 1 year of experience in medical device product registration, preferably in Class III active medical devices;
3. Familiar with quality management system, medical device production quality management specifications and other laws and standards, with ISO13485 internal auditor certificate.
5. Good communication and coordination skills; Work meticulously, rigorously, actively and methodically, with a high sense of responsibility and good team spirit.
