Philips Regulatory Affairs Assistant Manager in Beijing, China
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.
Duties and responsibilities include:
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
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.