Job Information
Philips Regulatory Affairs Manager in Beijing, China
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.
The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
In this role, you have the opportunity to make life better
Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.
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. Mainly focus on localized innovation projects.
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)
Review changes in existing products to determine need for new/revised submissions or document reason for no submission.
Maintain existing regulatory filings /Licenses, managing updates and related change control processes (generally at the BIU and field level)
You are a part of
- A progressive and energetic team that contributes directly to the growth of the business.
To succeed in this role, you should have the following skills and experience
Bachelor’s degree above, major in medical or engineer
More than 5 years experiences in RA area, it is better if has the RA experience in intravascular medical device.
Be familiar with NMPA regulation, standard and guidance, also international regulations
Good in written and spoken in English and Mandarin
Excellent communication and interpersonal skill
How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
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