Regulatory Affairs Manager

Job Title

Regulatory Affairs Manager

Job Description

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
• Other things assigned by your manager

You are a part of

Greater China RA team, based at Shanghai and reports to Senior RA manager.

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.

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.