Regulatory Affairs Manager [China]

 

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Job Title

Regulatory Affairs Manager

Job Description

In this role, you have the opportunity to

Be a part of team of build a high growth business that will help improve the lives of millions of men, while advancing Philips digital transformation journey as a global leader in Health Technology.

You are responsible for

• Developing regulatory strategies for new device registrations and re-registrations/notifications in China, the US, and the EU.
• Managing, preparing, and submitting product registration documents on time to obtain or maintain marketing approval and import licenses, ensuring compliance with NMPA regulatory requirements.
• Participate and provide regulatory guidance and support to cross-functional teams (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc.
• 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 regulation changes, standards, country-specific issues, or other unique project characteristics.
• Communicate application progress to internal stakeholders
• Collaborate with worldwide colleagues regarding license renewals and updates

You are a part of

• Be considered a key regulatory point person to enable regulatory compliance in the region.
• Be an impactful member of the Regulatory Affairs (RA) team and trusted by management as an independent regulatory team member on multiple projects simultaneously.

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

• Bachelor’s Degree & minimum of 5 years’ experience in the medical device industry or with medical product regulatory agencies. Experience of Class III active medical device registration with NMPA is strongly preferred.
• Ability to prioritize, plan & evaluate deliverables to established strategic goals.
• Proven application of analytical skills in a regulatory environment.
• Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English.
• Demonstrated knowledge & experience conducting scientific, regulatory or business research.
• Strong problem solving and negotiation skills.
• Ability to work well independently & in a team setting.
• Knowledge of Quality Management Systems (QMS).
• Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.

In return, we offer you

We offer experiences and opportunities that add many unexpected and enriching moments to our employees’ lives. Especially when the innovative health technologies and solutions they help develop benefit their own friends and family.

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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