RA Assistant Manager
- 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.
In return, we offer you
Describe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.
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.
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.
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Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven.
Little did they realize that it would become a global force of innovation, committed to
improving billions of lives worldwide. But it did.
Today, Philips is a world leading health technology company with a vision to make life better
for people worldwide through meaningful innovation. Making good on this promise depends on our
passionate, inspirational, collaborative and diverse team.
We have over 80,000+ brilliant people around the world but are always looking for more.
Like-minded, motivated, focused minds to join us in creating a healthier, more connected society
while tranforming themselves personally and professionally.
Working at Philips is more than a job. It's an experience filled with unexcepted moments that
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