Job TitleRegulatory Affairs Manager
In this role, you have the opportunity to
- Coordinate, review, and file new device registration/approvals and amendments to existing products for market access into the Peoples Republic of China. Communicates with relevant competent authorities, agents, distributors and local sales offices to ensure the most efficient path to application approval.
- Advise local and international teams on the most expedient route to obtaining product licenses, and ensure market access strategy is aligned with local and international marketing/sales requirements. To resolve any conflicts of strategy with marketing/sales strategies and determine the regulatory impact of such strategy on license approval timescales.
You are responsible for
- Participate in and advise cross-function new product/solution development teams on applications, requirements, and standards(not in the field)
- Review development quality reports and plans to ensure that the information required for submissions is adequate;
- Plan, generate, and coordinate regulatory submissions for product/solution licensing;
- Coordinate testing required to support regulatory submissions;
- Review and approve product/solution labeling and product/solution-related marketing communications(generally at BIU and Field)
- Maintain existing regulatory filings /Licenses, managing updates and related change control processes(generally at the BIU and field level)
You are a part of
Great china Q&R team
To succeed in this role, you should have the following skills and experience
- Bachelor degree above, major in medical or engineer
- More than 5 years experiences in RA area, it is better if has the experience in medical device.
- Be familiar with China CFDA and international regulations
- Good in written and spoken in English and Mandarin
- Excellent communication and interpersonal skill
- Self-starter and able to work both autonomously and as part of a team
- Good problem solving, learning, project management skill
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a complex environment 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 competitive health benefits, a flexible work schedule and access to local well-being focused activities.
- A professional but fun workplace, A healthy work-life balance environment;
- An energetic, genuine, inventive, supportive 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.
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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 inclusive, passionate, inspirational, collaborative and diverse team.