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Norm Compliance Officer IGT Systems - already living in the Netherlands In this role, you have the opportunity to: Be part of the Norm Compliance team, support the Norm Compliance activities and deliverables for IGT- systems with all relevant mandatory international and national regulations including MDR and Philips Healthcare processes.Participate in a cross functional development team, representing the Norm Compliance team, develop and execute the standards and compliance plan. You are responsible for: -
Defining, for products to be developed, the applicable standards and regulations such as IEC 60601 series, IEC 62304, IEC, 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 To succeed in this role, you should have the following skills and experience: -
A bachelors 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 (, 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 successRelated to the standards in the medical domain, knowledge on the following standards is preferred: IEC60601-1 series including collateral- and X-ray related particular standards. IEC62304 and IEC62366-1 EU MDR and 21CFR820 Artificial intelligence related standards and regulations
Defining, for products to be developed, the applicable standards and regulations such as IEC 60601 series, IEC 62304, IEC, 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 To succeed in this role, you should have the following skills and experience: -
A bachelors 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 (, 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 successRelated to the standards in the medical domain, knowledge on the following standards is preferred: IEC60601-1 series including collateral- and X-ray related particular standards. IEC62304 and IEC62366-1 EU MDR and 21CFR820 Artificial intelligence related standards and regulations