In this role, you have the opportunity to
61 Provide appropriate global regulatory strategy and planning for new product introductions and product change; Ensure timely and well-organized registrations activities; Provide guidance on risk assessment, clinical evaluation and required corrective actions to meet regulatory requirements.

You are responsible for
61 Responsible for implementing global regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy.
61 Advise product design teams on regulatory strategy and requirements for specific new products/solutions.
61 Responsible for regulatory planning for new product introductions and product changes and assist in maintaining regulatory compliance.
61 Support development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and Product registrations such as CE Marking and clinical evaluations.
61 Develop and facilitates regulatory submissions for new products/solutions, existing products/solutions.
61 Creates, review and validate marketing and labeling materials while supporting projects and other key regulatory initiatives

You are a part of
61 Professional Regulatory Team, with around 10 team peers globally.

To succeed in this role, you should have the following skills and experience
61 BS in science, engineer or regulatory affairs.
61 Minimum of 5 years’ experience in active medical device regulatory affaire role.
61 Be skillful in EU BS in science, engineer or regulatory affairs.
61 Minimum of 5 years’ experience MDD/MDR, FDA and China NMPA registration.
61 Be familiar with global regulation requirements.
61 Proficient in English and Chinese communication including reading, writing, speaking and listening.
61 Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
61 High efficiency on problems solving from RA perspective.
61 Capable of handling pressures during work.
61 Willing to communicate and cooperate with cross-function team members.
61 Strong ability in organizing CFT to finish tasks on time.
61 Willing to take ownership and capable of delivering fast.