Regulatory Affair Program Lead

4 weken geleden

Best, Noord-Brabant, Nederland Philips Voltijd
Job TitleRegulatory Affair Program LeadJob Description

Focus primarily on managing the standards and regulation roadmap and Leading improvements within the Image Guided Therapy systems (IGT-S) team. Understanding the regulations and standards is a plus not a must as this is not a regulatory content role.

Your role:
Program Manager for Regulatory Affairs plays a crucial role in ensuring that an organization's products and processes adhere to regulatory standards, and they work to establish and maintain positive relationships with other Program Managers.

The position requires a combination of regulatory knowledge, project management skills, and effective communication across various departments and with external stakeholders.

You are responsible for:

  • Work according to the business applicable processes and as ambassador of the Philips values.
  • Keeps abreast of current regulatory procedures and changes and driving these with the key SMEs across the company
  • Responsible for developing and implementing global RA roadmaps within IGT-S portfolio.
  • Collaborating with cross-functional teams spanning the globe in the business and markets in the chartering, initiation and executing of programs
  • Managing internal communications related to ensure clarity, agreement and efficiency which includes reporting out to IGTS Management Team and parts of the Philips Executive Committee
  • Driving best practice project management processes throughout projects and promote the consistent use of appropriate tools and methodologies.
  • Managing ongoing project coordination, risk, project dependencies and issue resolution and escalations.

You're the right fit if:

  • Strong communication skills
  • 10+ years of experience in leading and managing programs using formal program & project management processes
  • 5+ years of experience in continuous improvement activities
  • 5+ years of experience in change management activities
  • Experience in relevant positions in medical device manufacturing organizations, professional services organizations, healthcare delivery organizations, or in consultancies serving those organizations highly preferred
  • Affinity with medical device regulations (21CFR), FDA Law, MDD, MDR, other global laws and regulations.
  • Green belt/black belt certification (is plus)
  • Able to travel up to 20%

About Philips

We 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.

• Learn more about our business.

• Discover our rich and exciting history.

• Learn more about our purpose.

If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

#LI

  • Regulatory Affairs Manager

    2 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job Title: Regulatory Affairs ManagerJob Description:You will be part of the Global Regulatory Affairs team for Magnetic Resonance within Imaging Business and will play a key role in influencing and shaping the regulatory capabilities for the future success of Philips.Your role will include:Preparing and submitting product registration files to obtain or...

  • Regulatory Affairs Manager

    1 maand geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleRegulatory Affairs ManagerJob DescriptionYou will be part of the Global Regulatory Affairs team for Magnetic Resonance within Imaging Business and, therefore, influence and shape the regulatory capabilities for the future success of Philips.Your role you will be:Preparing and submitting product registration files to obtain or to keep marketing...

  • Regulatory Affairs Manager

    2 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleRegulatory Affairs ManagerJob DescriptionYou will be part of the Global Regulatory Affairs team for Magnetic Resonance within Imaging Business and, therefore, influence and shape the regulatory capabilities for the future success of Philips.Your role you will be:Preparing and submitting product registration files to obtain or to keep marketing...

  • Regulatory Affairs Manager

    4 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleRegulatory Affairs ManagerJob DescriptionYou will be part of the Global Regulatory Affairs team for Magnetic Resonance within Imaging Business and, therefore, influence and shape the regulatory capabilities for the future success of Philips.Your role you will be:Preparing and submitting product registration files to obtain or to keep marketing...

  • Regulatory Affairs Manager

    1 maand geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    You will be part of the Global Regulatory Affairs team for Magnetic Resonance within Imaging Business and, therefore, influence and shape the regulatory capabilities for the future success of Philips.Your role you will be: Preparing and submitting product registration files to obtain or to keep marketing approval and import licenses per local regulatory...

  • Regulatory Affairs Manager

    2 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    You will be part of the Global Regulatory Affairs team for Magnetic Resonance within Imaging Business and, therefore, influence and shape the regulatory capabilities for the future success of Philips.Your role you will be: Preparing and submitting product registration files to obtain or to keep marketing approval and import licenses per local regulatory...

  • Regulatory Affairs Manager

    4 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    You will be part of the Global Regulatory Affairs team for Magnetic Resonance within Imaging Business and, therefore, influence and shape the regulatory capabilities for the future success of Philips.Your role you will be: Preparing and submitting product registration files to obtain or to keep marketing approval and import licenses per local regulatory...

  • ISC Transformation Program Manager

    4 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleISC Transformation Program ManagerJob DescriptionPhilips 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...

  • ISC Transformation Program Manager

    1 maand geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleISC Transformation Program ManagerJob DescriptionPhilips 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...

  • ISC Transformation Program Manager

    1 maand geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleISC Transformation Program ManagerJob DescriptionPhilips 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...

  • ISC Transformation Program Manager

    4 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleISC Transformation Program ManagerJob DescriptionPhilips 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...

  • ISC Transformation Program Manager

    2 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleISC Transformation Program ManagerJob DescriptionPhilips 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...

  • Senior Director Program Management Office Image Guided Therapy Systems

    1 maand geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleSenior Director Program Management Office Image Guided Therapy SystemsJob DescriptionAs Senior Director Program Management Office for Image Guided Therapy Systems (IGTS), you will be End to End responsible for leading projects/programs, prioritization, planning and execution of our project road map and business benefits realization. As the Program...

  • Senior Director Program Management Office Image Guided Therapy Systems

    4 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleSenior Director Program Management Office Image Guided Therapy SystemsJob DescriptionAs Senior Director Program Management Office for Image Guided Therapy Systems (IGTS), you will be End to End responsible for leading projects/programs, prioritization, planning and execution of our project road map and business benefits realization. As the Program...

  • Senior Director Program Management Office Image Guided Therapy Systems

    2 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleSenior Director Program Management Office Image Guided Therapy SystemsJob DescriptionAs Senior Director Program Management Office for Image Guided Therapy Systems (IGTS), you will be End to End responsible for leading projects/programs, prioritization, planning and execution of our project road map and business benefits realization. As the Program...

  • Senior Director Program Management Office Image Guided Therapy Systems

    2 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    JOB DESCRIPTION Job Title Senior Director Program Management Office Image Guided Therapy Systems Job Description As Senior Director Program Management Office for Image Guided Therapy Systems (IGTS), you will be End to End responsible for leading projects/programs, prioritization, planning and execution of our project road map and business benefits...

  • Validation Lead

    1 maand geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleValidation LeadJob DescriptionLead the design validation strategy and evidence collection for innovative clinical solutions in medical imaging, ensuring regulatory compliance and optimal customer outcomes in the Image Guided Therapy (IGT) iApps organization at Philips.Your role:This role significantly contributes to advancing healthcare technology...

  • Validation Lead

    4 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleValidation LeadJob DescriptionLead the design validation strategy and evidence collection for innovative clinical solutions in medical imaging, ensuring regulatory compliance and optimal customer outcomes in the Image Guided Therapy (IGT) iApps organization at Philips.Your role:This role significantly contributes to advancing healthcare technology...

  • ISC Transformation Program Manager

    4 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleISC Transformation Program ManagerJob DescriptionPhilips 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...

  • ISC Transformation Program Manager

    4 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleISC Transformation Program ManagerJob DescriptionPhilips 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...