Regulatory Affairs Manager

2 weken geleden

Best, Noord-Brabant, Nederland Philips Voltijd

Job Title:

Regulatory Affairs Manager

Job 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 maintain marketing approval and import licenses per local regulatory requirements for CE marked/FDA cleared devices in distribution countries.
  • Demonstrating a good understanding of UDI/EUDAMED and GTINs.
  • Expanding regulatory knowledge of responsible geographies by collaborating with local Philips Entities, Distributors, and Regulatory Intelligence sources.
  • Identifying process optimization opportunities to enhance International Regulatory Affairs.
  • Providing accurate regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
  • Following Quality System procedures to ensure regulatory compliance.
  • Maintaining proficiency in regional regulatory requirements.
  • Ensuring regulatory and product data accuracy during regulatory changes or product updates.
  • Engaging in Global and Local Item Creation/Setup processes.

You're the right fit if you have:

  • Bachelor's/Master's degree in engineering/pharmacy/science preferred.
  • 5+ years of medical device experience with a bachelor's degree, or 3+ years of experience with a Master's degree, in Regulatory Affairs.
  • Excellent communication skills and experience in presenting to leadership.
  • Demonstrated experience in various types of International regulatory submissions.
  • Working knowledge of FDA, ISO 13485, EU MDR, and other regional regulations.
  • Ability to make timely decisions under tight deadlines.
  • Familiarity with PC hardware/software and proficiency in Microsoft Office Suite.

About Philips

We are a health technology company dedicated to ensuring that every individual has access to quality healthcare. Join us in making a difference and improving lives.

  • Learn more about our business.
  • Discover our rich and exciting history.
  • Explore our purpose.

If you meet most of the requirements for this role, we encourage you to apply as you might be the ideal candidate. Learn more about our commitment to diversity and inclusion.

  • 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

    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

    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

    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 Affair Program Lead

    1 maand geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleRegulatory Affair Program LeadJob DescriptionFocus 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...

  • QMS Manager

    1 maand geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleQMS ManagerJob DescriptionHold a pivotal position to disrupt Medtech and make a real difference for patients.The FORS group is a dedicated corporate venturing organization tasked to create new solutions for IGT, focusing on procedure innovation and new business model development in the cardio-vascular domain.FORS is a unique technology that enables...

  • Medical Safety Manager

    2 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    JOB DESCRIPTION Job Title Medical Safety Manager Job Description As the Medical Safety Manager, you will utilize your medical and clinical expertise to objectively assess safety risks and ensure the safety of Philip's medical devices throughout the product lifecycle. Your role will be focused within the Image Guided Therapy Systems (IGT-S) business. ...

  • Sr. Manager Quality Laboratory

    1 maand geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleSr. Manager Quality LaboratoryJob DescriptionAt the Innovation Campus in Best, Philips has an inhouse, ISO 17025 certified test laboratory to support various business units with independent norm compliance testing services: in addition to calibration services (CMS) for monitoring and measurement tooling. In this role, you represent the Quality...

  • Medical Safety Manager

    4 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    As the Medical Safety Manager, you will utilize your medical and clinical expertise to objectively assess safety risks and ensure the safety of Philip's medical devices throughout the product lifecycle. Your role will be focused within the Image Guided Therapy Systems (IGT-S) business.Your work will directly influence product development, quality, and...

  • Medical Safety Manager

    2 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleMedical Safety ManagerJob DescriptionAs the Medical Safety Manager, you will utilize your medical and clinical expertise to objectively assess safety risks and ensure the safety of Philip's medical devices throughout the product lifecycle. Your role will be focused within the Image Guided Therapy Systems (IGT-S) business.Your work will directly...

  • Medical Safety Manager

    4 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleMedical Safety ManagerJob DescriptionAs the Medical Safety Manager, you will utilize your medical and clinical expertise to objectively assess safety risks and ensure the safety of Philip's medical devices throughout the product lifecycle. Your role will be focused within the Image Guided Therapy Systems (IGT-S) business.Your work will directly...

  • Senior FCO Manager

    2 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    The FCO manager is responsible for managing/driving the FCO process E2E.Your role: Development/improvement of processes for engagement with key contributors (e.g., BIUs/BGs, Quality & Regulatory (Q&R), Reconciliation Team, FCO BPE, R&D, etc. to ensure execution of FCO meets targeted FCO project/program timelines.) Lead Programs to enable Remote deployment...

  • Quality Engineer

    1 maand geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleQuality EngineerJob DescriptionAs a Quality Engineer you will be responsible to support, guide and help our Ambient Experience business towards a higher maturity level.Your role will be vital for developing our products to the required Safety and Quality standards for our Customers and Patients.Your role:Support, guide and help the organizational...

  • Product Manager, DCP

    1 maand geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleProduct Manager, DCP (Digital Computational Pathology)Job DescriptionProduct Manager Digital Computational Pathology (DCP):Own the DCP product strategy, product requirements, solution and services development, launch and life-cycle management or their enhancements, driven by global and local market needs, a deep understanding of customer needs and...

  • EMC Test Engineer

    2 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Execute objective and reproducible EMC tests of the Quality Laboratory (QLAB). You will interpret and report test results and report to the Manager Quality Laboratory.Your role Interpret test designs and independently plan and perform tests Create and build test set-ups compliant to the international EMC standards Validate test set-ups, by executing and...

  • EMC Test Engineer

    2 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleEMC Test EngineerJob DescriptionExecute objective and reproducible EMC tests of the Quality Laboratory (QLAB). You will interpret and report test results and report to the Manager Quality Laboratory.Your role Interpret test designs and independently plan and perform tests Create and build test set-ups compliant to the international EMC standards ...

  • EMC Test Engineer

    4 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleEMC Test EngineerJob DescriptionExecute objective and reproducible EMC tests of the Quality Laboratory (QLAB). You will interpret and report test results and report to the Manager Quality Laboratory.Your role Interpret test designs and independently plan and perform tests Create and build test set-ups compliant to the international EMC standards ...

  • EMC Test Engineer

    4 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Execute objective and reproducible EMC tests of the Quality Laboratory (QLAB). You will interpret and report test results and report to the Manager Quality Laboratory.Your role Interpret test designs and independently plan and perform tests Create and build test set-ups compliant to the international EMC standards Validate test set-ups, by executing and...

  • Product Manager, DCP

    1 maand geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    Product Manager Digital Computational Pathology (DCP):Own the DCP product strategy, product requirements, solution and services development, launch and life-cycle management or their enhancements, driven by global and local market needs, a deep understanding of customer needs and commercial success criteria.Your role: Own lifecycle management (including...

  • Product Marketing Manager

    2 weken geleden

    Best, Noord-Brabant, Nederland Philips Voltijd

    JOB DESCRIPTION Job Title Product Marketing Manager Job Description As a Product Marketing Manager, you will be responsible for Spectral Computed Tomography (CT) portfolio downstream activities including product launch, market activation, sales support, and enablement. You'll be the main contact person for the markets for commercial activities. The...