In this role, you have the opportunity to
Develop, modify and execute regulatory strategies and policies for specific new products and solutions for Connected Care (CC) and medical products from Personal Health (PH).
You will lead regulatory team and resources to ensure timely product registration; regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
You will also support regulatory investigation notifications, approval requests to applicable authorities, ensuring compliant, effective and efficient RA processes.
You are responsible for
Advise business RA teams on applicable regulations, requirements, and standards through the development of regulatory plans.
Lead RA programs to ensure the highest level of compliance.
Develop market submission strategy for new products/solutions (to include definition of all deliverables and/or localization required).
Direct markets medical product approvals process and submissions when relevant.
Plan, generate, manage and coordinate regulatory submissions for product/solution licensing.
Coordinate testing required to support regulatory submissions.
Maintain existing regulatory filings/ licenses, managing updates and related change control processes.
Establish and deploy systems to ensure the information required for all required reports, product registration, certificate renewals and submissions is clearly identified and can be easily retrieved. This includes the creation of a central location for regulatory teams and distributors to access regulatory documents and certificates for worldwide product registrations and approvals.
Review and approve localized product/solution labeling and product/solution-related marketing communications and ensure that all medical and technical claims are underpinned with evidence obtained by business.
You are part of
Regulatory Affairs team. You will base in Beijing or Shanghai, leading a team of 10 members. You will report to Head of Regulatory, Medical & Clinical Affairs, Greater China.
To succeed in this role, you should have the following skills and experience
Master’s degree, preferably in a life-scientific discipline, and a minimum of 15 years of experience working in regulatory affairs organization within a global medical device industry, of which 7 years were in a senior leadership role.
Proven leadership in formulating and implementing global strategies to ensure compliance with worldwide regulations to maximize product market access.
A comprehensive understanding of the diverse Greater China medical device regulations, the experience to know how to successfully apply those regulations in an efficient, effective and compliant manner
Proven experience in understanding consequences of new and changing regulations to markets and business groups and effectively and pro-actively transferring this knowledge and understanding to all applicable stakeholders to ensure timely compliance with these regulations and guaranteeing continuous market access.
An ability to successfully lead virtual teams of RA professionals existing of both direct and functional reports in order to effectively and efficiently execute pre-market approval and post-market surveillance processes.
Proven experience in successfully representing organizations in industry associations
The experience to lead and develop strategies for a multi-site, global healthcare business while also being able to design and execute specific projects and lead teams.
In return, we offer you
A path towards your most rewarding career. Succeeding in this role 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 ambitious health benefits, a flexible work schedule and access to local well-being focused activities. You will also enjoy a professional but fun workplace, a healthy work-life balance environment and an energetic, authentic, inventive, encouraging 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 .
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 .