Job TitleAssistant RA 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
- Provide regulatory guidance and strategies for timely CFDA approvals.
- Ensure that regulatory strategy for current and future products in China to align with the BU and local business strategic plan
- Make submission plan and implement it according to the RA timeline for new , upgrade and renewal products in China. Meet the CFDA approval target
- Assist team members in resolution of priority conflicts and capacity constraints to ensure that registration plans are managed to successfully meet regulatory commitments and strategic business objectives.
- Ensure consistency, completeness and adherence to standards for regulatory submissions.
- Provide guidance to the organization in all phases from product development, through application approval, and post-market activities for China.
- Act as primary interface with BU regulatory teams providing guidance and communication of established submission processes and standards
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.
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