Senior Regulatory Compliance Expert for IGT Systems

1 week geleden


Best, Noord-Brabant, Nederland Yacht Voltijd
Company Overview
As a global leader in health technology, Philips is dedicated to improving people's lives through meaningful innovation. Our commitment to enhancing patient outcomes and advancing healthcare systems drives us to provide a wide range of solutions spanning medical devices, diagnostics, and digital health.

Job Description
The Regulatory Compliance Officer - IGT Systems will support the Norm Compliance team's efforts and deliverables for IGT-systems that adhere to all applicable national and international laws, including Philips Healthcare procedures and MDR. This role requires developing and implementing standards and compliance plans while serving as a representative of the Norm Compliance team in cross-functional development teams.

Required Skills and Qualifications
To succeed in this role, you should have expertise in identifying relevant standards and laws (e.g., EU MDR, IEC 60601, IEC 62304, IEC 62366-1) to design products. You should also be able to define the plan to incorporate rules and guidelines for demonstrating compliance and create deliverables for norm compliance. Additionally, assisting testers and designers in interpreting and evaluating rules and guidelines pertaining to technical design is essential. Furthermore, assembling and finishing documentation required for independent certifying bodies to certify products and providing technical support to the Regulatory Affairs division are crucial aspects of this role. It is preferred to have knowledge in the following medical domain standards: IEC 60601-1 series, including collateral and X-ray-related standards; IEC 62304 and IEC 62366-1; EU MDR and 21 CFR 820; and AI-related standards and regulations.

Benefits
This position offers a competitive salary based on industry standards, considering degree and experience. The annual salary ranges from €65,000 to €85,000 depending on qualifications and performance. Additional benefits include a 13th month salary, 8.33% holiday pay, pension scheme, home workplace allowance, quarterly bonus, vacation days, travel expenses reimbursement, yacht academy training budget, and referral bonuses.
  • Compliance Expert

    2 weken geleden


    Best, Noord-Brabant, Nederland Yacht Voltijd

    At Philips, we're committed to improving lives through meaningful innovation. As a Compliance Expert for IGT Systems, you'll play a critical role in ensuring our products meet all applicable national and international laws.About the RoleThis is a highly sought-after position that requires a strong understanding of regulatory compliance, particularly in the...


  • Best, Noord-Brabant, Nederland Yacht Voltijd

    Please note:Please list all the required knowledge and answer YES and an explanation, in addition to the CVWe would like to receive a CV that clearly shows that you meet the strict requirements. Although we work with deadlines, it is possible that the project will still be closed earlier. We advise you to respond as soon as possible.Regulatory Compliance...


  • Best, Noord-Brabant, Nederland Yacht Voltijd

    Company OverviewPhilips, a global leader in health technology, is dedicated to enhancing patient outcomes and advancing healthcare systems. With a strong focus on delivering high-quality, sustainable products, the company provides a wide range of solutions spanning medical devices, diagnostics, and digital health.The company's commitment to making a positive...


  • Best, Noord-Brabant, Nederland Yacht Voltijd

    About YachtYacht is a dynamic and international company offering challenging positions that allow professionals to grow and develop in a fast-paced environment. We are seeking a Regulatory Compliance Specialist to join our team.Job DescriptionThe Regulatory Compliance Specialist will be responsible for providing support in the development of Standards and...

  • Senior Systems Engineer

    3 weken geleden


    Best, Noord-Brabant, Nederland Philips Voltijd

    About the Role:As a Senior Systems Engineer at Philips, you will be responsible for ensuring the safety and reliability of our Image Guided Therapy systems. This includes supporting new product introductions, post-market surveillance, and maintenance initiatives. You will work closely with cross-functional teams to drive safety risk assessment and risk...


  • Best, Noord-Brabant, Nederland Philips Voltijd

    Job Title: Senior Systems EngineerJob Description:We are seeking an experienced Senior Systems Engineer to join our team at Philips. In this role, you will be responsible for leading product safety risk management activities related to our Azurion and Allura IGT platforms.Your Role:Support in the execution of product safety risk management activitiesActively...


  • Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleCommercial and Sales Excellence Director for IGT-S Services & SolutionsJob SummaryWe are seeking a Senior Commercial Director to lead our Commercial and Sales Excellence program for IGT-S Services & Solutions. The ideal candidate will have a strong background in CRM marketing, commercial management, and services sales and marketing. The role will...

  • CAPA Program Manager

    4 weken geleden


    Best, Noord-Brabant, Nederland Philips Voltijd

    Job Title: CAPA Program ManagerAbout the Role:We are seeking a highly skilled CAPA Program Manager to join our team at Philips. As a CAPA Program Manager, you will be responsible for ensuring that CAPAs (Corrective Actions & Preventive Actions) in business unit Image Guided Therapy (IGT) Systems are processed appropriately.Key Responsibilities:Leading and...


  • Best, Noord-Brabant, Nederland Philips Voltijd

    Job Title:Commercial and Sales Excellence Director for IGT-S Services and SolutionsJob Description:As a Commercial and Sales Excellence Director for IGT-S Services and Solutions, you will be responsible for driving the commercial and sales excellence enablement program for the IGT-S business unit. Your primary goal will be to secure and enhance customer...


  • Best, Noord-Brabant, Nederland Yacht Voltijd

    Company OverviewAt Philips, we strive to be a global leader in health technology, dedicated to enhancing lives through meaningful innovation. Our focus on patient outcomes and advancing healthcare systems drives us to provide cutting-edge solutions spanning medical devices, diagnostics, and digital health.We are committed to delivering high-quality,...


  • Best, Noord-Brabant, Nederland YER Nederland Voltijd

    Vacature: Senior Regulatory Affairs ManagerIn onze zoektocht naar een senior medische apparaat- en uitrusting specialist met een sterke achtergrond in regulatory affairs, hebben wij een opwindende uitdaging voor jou!Als senior regulatory affairs manager zorg je ervoor dat onze innovatieve producten voldoen aan de strikte regelgeving en veiligheidsnormen. Je...


  • Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleDrive Commercial and Sales Growth in Medical Services and Solutions.About the RoleWe are seeking a seasoned professional to lead our commercial and sales excellence efforts for IGT-S (Image Guided Therapy) Services & Solutions. As a Sales Excellence Director, you will be responsible for driving customer acquisition, success, and retention across...


  • Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitlePrincipal Design Quality EngineerJob DescriptionYou will enhance patient safety and product quality for the IGT-Systems business by developing and deploying key design quality and reliability engineering skills.Your Role:Lead design quality and reliability improvements in new product introductions and sustaining developments.Collaborate across...


  • Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleTechnical Department Manager R&D Operations IGT-SJob DescriptionAs a Technical Department Manager R&D Operations, you will lead the R&D Operations department of approximately 15 engineers located in the Netherlands and India. Your key responsibilities will include defining the group composition, ensuring successful introduction and sustaining of...


  • Best, Noord-Brabant, Nederland Philips Voltijd

    Job Title: Senior C++ Software Engineer for Intravascular Imaging SuiteJob Description:We are seeking a talented Senior C++ Software Engineer to contribute to our industry-leading intravascular imaging and functional measurement application suite. This role involves working on the entire application development lifecycle, with responsibilities extending...


  • Best, Noord-Brabant, Nederland Philips Voltijd

    Job TitleSenior Correction and Removal Process ManagerJob DescriptionIn this role, you will contribute to the management of the Correction and Removal (C&R) process, collaborating with cross-functional teams to deliver solutions that meet regulatory requirements and customer needs.Your ResponsibilitiesOversee the complete correction and removal process to...


  • Best, Noord-Brabant, Nederland Alex Staff Agency Voltijd

    About the company:A European leader in developing cutting-edge embedded systems for healthcare, science, robotics, and high-tech products is seeking an experienced Senior Software Engineer.With over 25 years of market presence and a team of over 150 experts, they offer innovative and creative solutions in embedded software, web application software, and...


  • Best, Noord-Brabant, Nederland Trinamics Beheer B.V. Voltijd

    Job DescriptionWe are seeking a highly skilled Technical Expert to join our team at Trinamics Beheer B.V. as a Senior Field Service Engineer. In this role, you will play a key part in ensuring the seamless operation of advanced systems worldwide.Perform regular maintenance, troubleshoot, and repair complex systems to maintain optimal performance.Install and...


  • Best, Noord-Brabant, Nederland Philips Voltijd

    About the Role: We are seeking a dedicated Senior Product Quality Engineer to join our team at Philips. As a key member of our organization, you will be responsible for ensuring the quality and reliability of our medical products. Your expertise in reliability engineering, quality assurance, and regulatory compliance will be instrumental in driving our...


  • Best, Noord-Brabant, Nederland Philips Voltijd

    About the RoleWe are seeking a seasoned Commercial and Sales Enablement Leader to drive growth and success in our IGT-S Services & Solutions business unit. As a key member of our team, you will be responsible for developing and executing commercial strategies that align with our overall business objectives.