Philips International
Head of Regulatory Affairs - CT-AMI
Philips International, Hartford, Connecticut, United States,
Head of Regulatory Affairs - CT-AMI
In this role, you will lead the Regulatory Affairs Organization for our CT-AMI Business Unit, and be accountable for 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. The CT-AMI portfolio spans across imaging medical systems and software. There are key opportunities to build and strengthen Regulatory capabilities to drive software and AI applications, as well as drive efficiencies through regulatory operations excellence.Your role:Leading the Global CT-AMI 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 the Business Unit Regulatory Affairs team to efficiently and compliantly bring products to the market and maintain them compliantly to support business growth.Leading strategic AOP management to optimize revenue and expenditure.Leading strategy and execution of functional excellence to improve performance of the regulatory function and ultimately bring increased value to the CT-AMI 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.Providing critical input on regulatory risk assessments to support portfolio selection.Building 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.Leading and enabling 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're the right fit if you have 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 SaMD, AI and/or digital health is a significant advantage).Extensive experience and knowledge required of global medical device regulations, requirements, and standards.10 years of experience in people management – with a strong track record in successfully leading a Regulatory Affairs team.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).Experience with successful preparation and submission of Design Dossiers, 510(k), PMA, Technical /Design Dossiers and international documents or registration of medical device worldwide.About PhilipsWe are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.We’re committed to building a diverse and inclusive workplace culture where people feel heard, valued and connected. Because we know the possibilities are unlimited when people feel empowered to grow and succeed together.
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In this role, you will lead the Regulatory Affairs Organization for our CT-AMI Business Unit, and be accountable for 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. The CT-AMI portfolio spans across imaging medical systems and software. There are key opportunities to build and strengthen Regulatory capabilities to drive software and AI applications, as well as drive efficiencies through regulatory operations excellence.Your role:Leading the Global CT-AMI 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 the Business Unit Regulatory Affairs team to efficiently and compliantly bring products to the market and maintain them compliantly to support business growth.Leading strategic AOP management to optimize revenue and expenditure.Leading strategy and execution of functional excellence to improve performance of the regulatory function and ultimately bring increased value to the CT-AMI 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.Providing critical input on regulatory risk assessments to support portfolio selection.Building 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.Leading and enabling 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're the right fit if you have 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 SaMD, AI and/or digital health is a significant advantage).Extensive experience and knowledge required of global medical device regulations, requirements, and standards.10 years of experience in people management – with a strong track record in successfully leading a Regulatory Affairs team.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).Experience with successful preparation and submission of Design Dossiers, 510(k), PMA, Technical /Design Dossiers and international documents or registration of medical device worldwide.About PhilipsWe are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.We’re committed to building a diverse and inclusive workplace culture where people feel heard, valued and connected. Because we know the possibilities are unlimited when people feel empowered to grow and succeed together.
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