1. Prepare, generate and review the dossiers (include but not limited to CMC & Nonclinical & Clinical module) of Company’s products’ IND/NDA submission package; keep tracking the product registration process, response of evaluation comments from authority; handle the review issues timely with colleagues.
2. Execute the All life -cycle regulation affairs management of Company’s products.
3. Formulate the plan for domestic and international product registration strategies and tasks for review and approval.
4. Search and follow up and the regulations & guideline & tech documents which from domestic and overseas, provide policy support for company products’ submission dossiers.
5. Obtain the support of government affairs team of uUlm to maintain close communication with relevant medical device regulatory agencies and support regulatory affairs.

1.BS degree or above in a science-related discipline with above 6 years of regulatory experience in medical device company.
2.Comprehensive regulatory knowledge and understanding of medical device product development.
3. Familiar with the process and requirements for domestic and international registration and approval of medical devices, proficient in operating related businesses
4. Demonstrated experience in contributing to the preparation of regulatory submissions of the medical device products.
5. Excellent written and verbal communication skills and proficiency in English.
6. Proven leadership and project management skills, with the ability to work both as a team member and independently.