Role Profile - RA Specialist-口腔进口耗材

Main responsibilities:

• Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations;
• Manage regulatory project efficiently and independently.
• Lead working group to attain to target goals
• Perform gap analysis on SFDA requirement and propose solutions;
• Provide technical suggestion or help to other RAS as internal expert in some field
• Besides product submission, take responsible for RA internal program and projects
• Have a sound understanding of, and comply with the Company Compliance requirements.

Requirements:

• Bachelor’s degree or above in related scientific discipline; Medical, pharmaceutical, material science and engineering background is preferred
• With a minimum of 2 years regulatory experience as RA function in medical device industry
• Sound basis of Regulatory knowledge and Scientific Knowledge.
• Team management skill for small working group
• Skill to coach junior RA staff and help them to grow up
• Good communication skill and team work
• Strong oral and written communication in English and Chinese
• Ability to independently identify compliance risks and escalate when necessary;
• Good skill on Word, Excel and Powerpoint.