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Norm Compliance Officer - Koninklijke Philips N.V.

Eindhoven HBO Secondment via YER
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Quality & Safety
Medical & Health

Norm Compliance Officer - Koninklijke Philips N.V.

Eindhoven Quality & Safety Medical & Health HBO Secondment via YER
Koninklijke Philips N.V.

Summary

Eindhoven Medical & Health HBO Secondment via YER
Posted in:
Quality & Safety
Medical & Health
About this vacancy

Norm Compliance Officer binnen Philips gericht op de Medical Devices

  • Defining, for products to be developed, the applicable standards and regulations such as e.g. IEC 60601 series, IEC 62304, IEC 62366-1, EU MDR
  • Defining within the Standards and Compliance plan how the required standards and regulations will be covered into evidence for demonstrating compliance
  • Creating project deliverables related to Norm Compliance responsibilities
  • Securing the implementation and verification of all specified legal requirements by reviewing these related project deliverables
  • Supporting designers and testers with the interpretation and testing of standards and regulations with respect to the technical design of IGT products
  • Arranging and completing all evidence for gaining product certification by the independent certifying agency
  • Providing the Regulatory Affairs department with technical support as preparation of submission to Regulatory bodies and countries


With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.
  • Dependable on work experience
  • A bachelor’s degree or higher in a technical field, health sciences, or related
  • At least 3-5 years in Software and/or hardware Testing/Engineering or experience in similar roles within a complex environment
  • A background in the global medical devices industry would be considered a strong plus
  • Knowledge of product safety standards (e.g., IEC 60601) would be preferred
  • Familiarity with other national and international regulations is an advantage
  • Well-developed project management skills would be preferred
  • Proven experience in improvement activities and audits is an advantage
  • Team player that can influence environment for project success

The steps to a successful match

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If you respond to an appealing job opening, the consultant will contact you to schedule an exploratory meeting in the next few days.

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Analysis

Together with the consultant, you determine whether your profile is a good fit for the position. You also assess whether your ambitions are aligned with the direction of the organi…

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Initial interview

If the fit is right on both sides, there will be a first-round interview with your potential new employer in the next two weeks.

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Follow-up interview(s)

Depending on the process, the consultant will invite you to the next round(s) of interviews and possibly an assessment center.

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Offer

If you are selected for the position, you will receive an attractive job offer. We will be happy to advise you on realistic terms of employment.

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