工作职责



* Be responsible for assigned regulatory tasks for new product registration,
license variation and renew of digital health in China, including drafting
project strategy and plan, organize product local testing, documents
preparation and submission, and CMDE reviewer communication for license
approval.
* Ensure the regulatory compliance for responsible digital health products in
China during the whole lifecycle of products. Manage the product labeling to
compliant with regulatory requirements. Evaluate the impact of product changes
to be in line with the product variation plan.
* Track the China regulatory, policy and standard changes regarding to
digital health Participant in the internal and external communication to
evaluate the intelligence impact on responsible products.
* Ensure compliance for Promotional Material of digital health products by
timely review.
* Coordinate with cross functional teams to provide regulatory advice in
digital health area.


任职要求



* Bachelor/Master of Science.
* Above 3 years medical device regulatory experience.
* Fluent English.