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Head of Regulatory Affairs – IGT-D

Job Title

Head of Regulatory Affairs – IGT-D

Job Description

Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*.  Employees may request a reasonable accommodation. *Montana employees are currently excluded from this requirement at this time.

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request.  You may contact 888-367-7223, option 5, for assistance.

In this role, you have the opportunity to make life better

You will help create value with sustainable impact, delivering scalable, people and patient-centric innovation for patients, consumers and customers.  This includes the generation and maintenance of healthcare solutions that help achieve improved clinical outcomes at a lower cost with improved clinician and patient experience.

You will lead the Regulatory Affairs Organization for the Image Guided Therapy Devices (IGT-D) Business Unit, accountable for advanced tools and technologies designed to innovate minimally-invasive, interventional procedures across the clinical domains of coronary, peripheral vascular and heart rhythm management.  The RA leader will drive the development and deployment of innovative, compliant regulatory strategies to grow and sustain the Philips portfolio, which drives Philips’ mission to improve the lives of 2.5 billion people by 2030.  There are key opportunities to build regulatory capabilities in minimally-invasive interventional devices, as well as drive efficiencies through regulatory operations excellence.

You are responsible for

• Leading the Global IGT-D Regulatory Affairs team from end to end (product inception through to lifecycle management), driving significant innovation, actively providing value-added regulatory affairs input and deliverables for new product introductions and product changes across the globe
• Leading performance management of the Business Unit Regulatory Affairs team, using metrics and key performance indicators to drive decision making, meaningful actions, and continuous improvement.
• Leading the development and deployment of innovative Regulatory strategies with Business Unit Regulatory Affairs team and cross-functional Business Unit teams, to efficiently and compliantly bring products to the market and maintain them compliantly to support business growth.
• Leading strategic AOP management to optimize revenue
• Leading strategy and execution of functional excellence to improve performance of the regulatory function and ultimately bring increased value to the IGT-D Business Unit.
• Providing interpretation of global regulations through the regulatory council.
• Managing the relationship and efficient flow of information between Business Unit and regional Regulatory Affairs teams
• Provide critical input on regulatory risk assessments to support portfolio selection
• Build proactive, robust, strategic relationships with external stakeholders (FDA, NBs, CAs, MedTech forums etc.) to influence and shape the external regulatory landscape across the domains relevant to the innovation agenda
• Lead and enable strong cross-functional partnership between Regulatory Affairs and all key stakeholders including R&D, Marketing, Quality, Clinical Affairs and other functions at all levels within the Business Unit.
• Responsible for the hiring and development of critical talent within the global Regulatory Affairs team through creating and sustaining robust career & development plans, ongoing coaching and feedback, and identifying and addressing gaps in capabilities and competencies.

You are a part of

You will be an integral team member of the IGT-D Business Unit and therefore, influence and shape the regulatory capabilities  and direction for the future success of the Business Unit.

To succeed in this role, you’ll need a customer-first attitude and the following

• Master’s degree, preferably in an engineering or life-scientific field;
• A minimum of 12 years of experience working in Regulatory Affairs within the medical device industry; Experience with US Class lll medical devices and PMAs is a significant advantage;
• Extensive experience and knowledge required of global medical device regulations, requirements, and standards;
• Proven track record of leading in a matrix organization, leading cross-functional and diverse teams with challenging goals;
• Experienced in strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities);
• 10 years of people management – with a strong track-record in successfully leading a Regulatory Affairs team

In return, we offer you

This offers you the opportunity and challenge to personally contribute to Philips’ achievement of growth objectives and ambition to improve people’s lives and well-being.  Your strong leadership will enable broader deployment of solutions that address some of society’s most pressing issues.  You will leverage your Regulatory Affairs strengths in driving a business with significant strategic opportunity; the ability to partner learn and grow from colleagues in a highly complex, global organization.

How we work at Philips
There are three core ways that define our ways of working – embracing flexibility, being at our best, and impactful collaboration. We believe this enables us to deliver an outstanding experience to our customers and create the best place to work for people who share our passion.

We know just how important direct interactions are and work is more engaging when we are more frequently face-to-face, and that we experience better collaboration which drives innovation. While we have many different types of roles across Philips most require a combination of in-person collaboration with colleagues and partners, usually at a Philips location, and individual focus time, which can be done remotely.

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.

Visit our careers website to explore what it’s like working at Philips, read stories from our employee blog, find information
about our recruitment process and answers to some frequently asked questions.

Learn more here

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

Job posted: 2023-05-24