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Job TitleNorm Compliance Officer
Job Description

You are responsible for:

Defining, for products to be developed, the applicable safety standards and regulations such as IEC 60601 series and/or IEC 62304, IEC 62366, the new EU MDR and Particular Standards IEC60601-2-43 and IEC60601-2-54
Defining within the Standards and Compliance plan how the required standards and regulations will be covered into evidence for demonstrating compliance.
The project deliverables related to Norm Compliance / Product Safety Certification 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 DXR 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
Own norm compliance portfolio for DXR products and execute end to end activities in accordance with regulations.
Work on the project deliverables related to Norm Compliance release evidence Generate Technical File for MDD & MDR certification.
Identification of relevant clauses from standards for (sub)system, Standards mainly includes IEC60601-1, IEC60601-2-43, IEC60601-2-54, etc.
Definition of product requirements to assure norm-compliance / Product Safety Certification.
Decomposition towards the individual (sub)system elements
Secure the implementation and verification of all specified legal requirements.
Support with respect to technical realization/engineering of norm compliance of the (sub) system.
Support the verification (testing, witnessing, and reporting and approval) of all specified legal requirements.
Be the intermediary between development and certifying/regulatory agencies (UL/CSA/TUV/FDA/BSI etc).
Test lab interaction experience.
Support arrangements for and completion of submission to certifying agencies.
Review standard updates and deploy revised standards.
Identification of approbation consequences due to change requests. (Notified Body Audits)
Train and inculcate design and cross functional teams on regulatory standards, update and execution.
Contributing to Technology Roadmaps
Build norm compliance team and coach them on various activities with the portfolio




You are a part of

Philips Healthcare Innovation Center (HIC) Pune is a product innovation center for multiple businesses with presence of R&D, Marketing, Customer Service, Procurement, Quality and Manufacturing functions. The center is focused on developing smart and reliable X-ray imaging based Diagnostics and Treatment products with enhanced patient safety to meet the unmet needs of a wide range of global hospital customer base. HIC Pune is the global head-quarters for the IGT Mobile Surgery business and it has a significant R&D presence for the Precision Diagnosis Cluster. In recent years, HIC Pune has become the hub for the growth of Diagnostic X-Ray, CT/AMI, MR and Imaging Components businesses.




To succeed in this role, you should have the following skills and experience

BE/BTech/ME/MTech in bio-medical / Electronics engineering having 8+ years of experience with minimum 3 years of experience in the X-ray system/subsystem design & development (or at least two end to end X-ray product development) (or experience of medical products safety certification & regulatory approvals).
Knowledge of relevant regulations (UL, CSA, IEC, ISO, MDR (CE mark), etc.) and relevant standards (General Safety, EMC, Radiation Safety, Risk Management, Environmental, Sustainability, etc.)
Knowledge on project organization, ISO 13485 and ISO 14971.
Knowledge of IEC 60601 standards, risk management, verification and validation of medical devices.
Knowhow of design control processes for medical device design.
Working knowledge of cabling design, design for EMI/EMC , Design for reliability.
Good team player and ability to work independently, act pro-actively, and drive for results.
Analytical, creative and abstract thinker.
Excellent communication skills - Ability to communicate (both written and verbal) on different levels.
Capable to introduce efficiency improvements on project level (change management).
System thinking mindset and domain expertise in the related area.
Fast learner and interest to learn new technologies/business/systems.
Be structured and self-organized.
Self-motivational, mindset to simplify and reach to solutions with speed.
Intercultural sensitivity.