Norm Compliance Officer

Job Title

Job Description

Norm Compliance Officer:

support the Norm Compliance activities and deliverables for IGT- systems with all relevant mandatory international and national regulations including MDR and Philips Healthcare processes.

Your role:

• Defining, for products to be developed, the applicable standards and regulations such as e.g. IEC 60601 series, IEC 62304, IEC 62366, the new 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

You're the right fit it:

• BSc/MSc degree in a technical field, health sciences or related

• Overall 11+ years of experience in the industry

• 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

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.

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.
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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 .