职位详情
Sr. Regulatory Affairs Specialist
面议
应届毕业生 学历不限
职位描述
In this role, you have the opportunity.
Provide appropriate L4L 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
Responsible for implementing regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy, especially the China market.
Advises product design teams on regulatory strategy and requirements for specific new products/solutions.
Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
Supports development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet NMPA regulatory requirements, and Product registrations.
Develops and facilitates regulatory submissions, for new products/solutions, existing products/solutions.
Creates, reviews and validates marketing and labeling materials while supporting projects and other key regulatory initiatives.
Develops and facilitates regulatory submissions, for new products/solutions, existing products/solutions.
Creates, reviews and validates marketing and labeling materials while supporting projects and other key regulatory initiatives.
You are a part of
Professional Regulatory Team, with around 10 team peers globally., report to RA Sr. Manager in Shenzhen.
To succeed in this role, you should have the following skills and experience
BS in science, engineer, or regulatory affairs.
Minimum of 5 years’ experience in active medical device regulatory affaire role.
Be skillful in key markets registration especially in China NMPA registration.
Be familiar with global regulation requirements.
Proficient in English and Chinese communication including reading, writing, speaking and listening.
Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
High efficiency on problems solving from RA perspective;
Capable of handling pressures during working;
Willing to communicate and cooperate with cross function team members;
Strong ability in organizing CFT to finish tasks on time;
Willing to take ownership and capable of delivering fast.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 2.5 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
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