Job Title Norm Compliance Officer Job title You are a part of the Ultrasound R D team - Pune Philips HIC Pune is playing a key role in Philips global strategy for Ultrasound With Philips HIC the foundation was laid to touch billions of lives and reiterate Philips commitment towards Indian and growth healthcare markets Your role Defining for products to be developed the applicable safety standards and regulations such as IEC 60601 series and or IEC 62304 IEC 62366 the current EU MDR and Particular Standards IEC60601-2-37 and in particular EMI EMC IEC 60601-1-2 standards and testing Defining within the Standards and Compliance plan how the required standards and regulations will be covered in evidence for demonstrating compliance Review standard updates and deploy revised standards Identification of approbation consequences due to change requests Notified Body Audits The 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 concerning the technical design of Ultrasound products Input to design reliability Electrical or Mechanical Arranging and completing all evidence for gaining product certification by the independent certifying agency Providing the Regulatory Affairs department with technical support for the preparation of submissions to Regulatory bodies and countries Own norm compliance portfolio for Ultrasound products and execute end-to-end activities according to regulations Work on the project deliverables related to Norm Compliance release evidence - Generate Technical File for CSA MDD MRDR certification Definition of product requirements to assure norm-compliance Decomposition towards the individual sub system elements Support concerning the technical realization engineering of norm compliance of the sub system Support the verif

📌 Norm Compliance Officer (Pune)
🏢 Philips
📍 Pune