Job Title

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 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.

You are responsible for
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• Actively participates in organizations in Standards Development both domestically as well as internationally where interested.     
• Actively participates in industry organizations to drive regulatory paradigms  including partnering with Global Regulations & Standards team on IMDRF and GHWP initiatives as appropriate.   
• Viewed as an expert by the company and in the field of regulatory.  Having a broad expertise or unique knowledge, uses skills to contribute to development of Philips objectives and principles and to achieve goals in creative and effective ways.  
• Engage in education and support of conformity assessment practices both in the area of Standards Development as well as deployment.  
• Has strong knowledge of electro-mechanical medical and consumer products and services including software. 
• Strong knowledge  in Global Regulations (Particularly US, EU, Japan ) to support leveraging and best practice sharing. 
• Strong knowledge of IEC/ISO rules of procedure and practices
• Advise business and market regulatory teams on applicable regulations, requirements, and standards throughout the TPLC supporting defining Philips’ policies and strategies as well as product specific strategies.  
• Lead and develop regulatory program(s) and processes to ensure the highest level of compliance
• Participates in corporate development of methods, techniques and evaluation criteria leveraging standards and regulations expertise,  including the ability to support development of project plans for resource planning and timelines to support optimal implementation.   
• Ability to develop and deploy training on standards development and standards & regulations assessment, deployment and implementation
• Ability to collect and analyze Philips inputs for consensus decisions

You are a part of

• This role reports solid line to the Head of Global Regulations and Standards and dotted line to the Head of China Regulations. 
• Position will have no direct reports but will be responsible for mentoring and guiding colleagues within team as well as globally across the functions, businesses and markets. 

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

• This position requires a Master’s degree, preferably in a life-scientific discipline, and a minimum of 12 years of experience working in NMPA agency or quality and regulatory affairs within a global medical device industry, of which 7 years were in an intelligence role.  
• Experience in working across the TPLC with Research and Development, Sales and Service, Manufacturing, Marketing, Purchasing/Procurement, Logistics and Service/Installation.  
• An advanced management degree is strongly preferred.
• Proven leadership in formulating and implementing global strategies to ensure compliance with worldwide regulations to maximize product market access.
• Proven experience on ability to communicate with key stakeholders
• Proven experience in Standards Development including horizontal and vertical standards.  Key areas of knowledge should include: software, conformity assessment requirements, quality management systems, risk management, alarms, labeling, symbols, sustainability and usability. 
• A comprehensive understanding of the diverse worldwide medical device regulations.
• 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 indirect and functional reports in order to effectively and efficiently execute pre-market approval and post-market surveillance processes with particular focus on conformity assessment and standardization.  
• Knowledge and use of continuous improvement initiatives and learning techniques. 
• 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.
• Knowledge and expertise in  key global standards  for example:  ISO 13485,  ISO 14971, ISO 80001, IEC 62304 and IEC 60601 standards.

ow 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.