Philips Assistant Regulatory Affairs Manager 

China, Beijing, Beijing 

391829707

Assistant Regulatory Affairs Manager

In this role, you have the opportunity to

• Government relations: Familiar with the officials and understanding their requirements for timely approvals.
• Regulations: In depth-understanding and application of SFDA and CQC regulations and the related regulatory process.
• Technical expertise: Knowledge of process and methods and medical product area such as product specifications, product developments / expansions and product safety.
• Understanding of the IEC and related GB standard for good communications with the BIU and CFDA or CQC testing lab’s engineers.
• Excellent communications skill with internal and external customers.

You are responsible for

• Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc.
• Create detailed written regulatory plans that can be used to target domestic and international shipment dates.
• Develop and take the ownership of China CFDA submissions
• Support Key market RA team on global registrations
• Establish active communications with regulatory agencies in China.
• Review and approve advertising, promotional items and labeling for regulatory compliance
• Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
• Communicate application progress to internal stakeholders
• Collaborate with worldwide colleagues regarding license renewals and updates
• Maintain regulatory files and tracking databases as required

You are a part of

RA Team You will base in Shanghai or Beijing

To succeed in this role, you should have the following skills and experience

• BS in engineering discipline or equivalent education, experience, training.
• At least 5 years regulatory experience in medical device industry.
• Experience in China local manufactured or local developed products will be a plus.
• Strong understanding of China FDA and other major international regulations
• Be able to manage multiple tasks and perform with accuracy and a high attention to detail

• Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.

• Proficient in English communication including reading, writing, speaking and listening.