Norm Compliance Officer

Bangalore, Karnataka
Permanent
Full-time

9 hours ago

Job Title Norm Compliance OfficerJob DescriptionNorm 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 MDRDefining within the Standards and Compliance plan how the required standards and regulations will be covered into evidence for demonstrating complianceCreating project deliverables related to Norm Compliance responsibilitiesSecuring the implementation and verification of all specified legal requirements by reviewing these related project deliverablesSupporting designers and testers with the interpretation and testing of standards and regulations with respect to the technical design of IGT productsArranging and completing all evidence for gaining product certification by the independent certifying agencyProviding the Regulatory Affairs department with technical support as preparation of submission to Regulatory bodies and countriesYou're the right fit it:BSc/MSc degree in a technical field, health sciences or relatedOverall 11+ years of experience in the industryAt least 3-5 years in Software and/or hardware Testing/Engineering or experience in similar roles within a complex environmentA background in the global medical devices industry would be considered a strong plusKnowledge of product safety standards (e.g., IEC 60601) would be preferredFamiliarity with other national and international regulations is an advantageWell-developed project management skills would be preferredProven experience in improvement activities and audits is an advantageTeam player that can influence environment for project successHow 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
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