Philips Sr. Regulatory Affaris Specialist in Beijing, China
lead registration projects and keep the target timeline;
maintain the regulatry compliance for the whole lifecyle of responsible products;
keep good communication with internal and external stakeholders and authorities.
Sr. RA Specialist
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
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
Great china Q&R team
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.
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .