Philips Regulatory Affairs Manager in Beijing, China
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 part of
Regulatory Affairs team. You will base in Beijing or Shanghai, and report to the Clinical Regulatory Affairs Director/Sr. Clinical Regulatory Affairs Manager, Greater China.
To succeed in this role, you should have the following skills and experience ：
BS in engineering discipline or equivalent education, experience, training.
At least 8 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. In return, we offer you A path towards your most rewarding career. Succeeding in this role will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer ambitious health benefits, a flexible work schedule and access to local well-being focused activities. You will also enjoy a professional but fun workplace, a healthy work-life balance environment and an energetic, authentic, inventive, encouraging and dynamic team atmosphere.
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 3 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.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.