Are you a RA Director passionate about leveraging the global and the local regulatory authority. If so, this opportunity could be for you! Join us in at B. Braun, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare!
As a RA Director at B. Braun Group you will play a vital role in providing high-quality registration service
Your key responsibilities:
- Lead the team to develop overall regulatory strategy for both import and localized medical devices aligned with overall business objectives and market conditions in alignment with business divisions. Provide proactive regulatory guidance to internal keystake holders to assess and mitigate regulatory risks.
- Manage registration progress by good collaboration with cross-functional China teams, including divisional Marketing and Sales, R&D, Manfacturing, MSA, Market Access and external regulatory authorities. Drive continuous process improvements and ensure compliance with global requirements and local regulations.
- Responsible for budget planning and control management to ensure project delivery and personnel cost are alligned with budget planning.
- According to the overall RA strategy, consistently build and develop team capability to enhance organizational overall capacity. Remain updated on regulatory guidelines and technical trends.
Education Background, Experience and Qualifications:
- Bachelor's degree or above in a science and engineering-related major
- Fluent English in writing, reading and speaking. Manderin is a must.
- Total working years >= 15 years in medical industry with 5 years above management experience on large team size (10+ employees).
- Solid knowledge of medical device regulatory submission procesures, with successful registration cases of Class III non-active consumables and active medical devices.