Philips Sr Regulatory Engineer 

China, Guangdong Province, Bao'an District 

869472121

Sr. Regulatory Engineer

In this role, you have the opportunity to

• 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

• Responsible for implementing regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy.
• Advice 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.
• Support development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and Product registrations.
• Create, review and validate marketing and labeling materials while supporting projects and other key regulatory initiatives
• Develop and facilitate regulatory submissions, for new products/solutions, existing products/solutions.

You are a part of

• Professional Regulatory Team, with around 10+ team peers globally.

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 EU MDD/MDR, FDA and China NMPA registration is required.
• Be familiar with global regulation requirements.
• Proficient in English and Chinese communication including reading, writing, speaking and listening.
• Require 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.

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