Job Title

Sr. Regulatory Affairs Specialist

Job Description

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.

• Provide appropriate L4L regulatory strategy and planning for new product introductions and product change; Ensure timely and well-organized registrations activities; Provide guidance on risk assessment, clinical evaluation and required corrective actions to meet regulatory requirements.
   

You are responsible for

• Responsible for implementing regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy, especially the China market.
• Advises product design teams on regulatory strategy and requirements for specific new products/solutions.
• Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
• Supports development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet NMPA regulatory requirements, and Product registrations.
• Develops and facilitates regulatory submissions, for new products/solutions, existing products/solutions.
• Creates, reviews and validates marketing and labeling materials while supporting projects and other key regulatory initiatives.
• Develops and facilitates regulatory submissions, for new products/solutions, existing products/solutions.
• Creates, reviews and validates marketing and labeling materials while supporting projects and other key regulatory initiative

You are a part of

• Professional Regulatory Team, with around 10+ team peers globally.

To succeed in this role, you should have the following skills and experience

• BS+ in science, engineer, or regulatory affairs.
• Minimum of 5 years’ experience in active medical device regulatory affaire role.
• Be skillful in key markets registration especially in China NMPA registration.
• Be familiar with global regulation requirements.
• Proficient in English and Chinese communication including reading, writing, speaking and listening.
• Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
• High efficiency on problems solving from RA perspective;
• Capable of handling pressures during working;
• Willing to communicate and cooperate with cross function team members;
• Strong ability in organizing CFT to finish tasks on time;
• Willing to take ownership and capable of delivering fast.

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.