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Philips Norm Compliance Officer in Pune, India

null In this role, you have the opportunity to support the Norm Compliance activity for Diagnostic X-ray (Radiography, Fluoro & Mammography) with all relevant mandatory international and national regulations including MDD & MDR and Philips Healthcare processes.

You are responsible for

  • 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 & MRDR certification.

  • Identification of relevant clauses from standards for (sub)system, Standards mainly includes IEC60601-1, IEC60601-1-2, IEC60601-1-3 etc.

  • Definition of product requirements to assure norm-compliance.

  • 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/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 Diagnostic X-Ray R&D team. Philips HIC, Pune is playing a key role in Philips global strategy for DXR. With Philips HIC, the foundation was laid to touch billions of lives and reiterate Philips commitment towards Indian and growth healthcare markets.

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

  • M.Tech/ME in bio-medical engineering having IQ specialization with 12+ years of experience with minimum 5 years of experience in the X-ray system/subsystem design & development (or at least two end to end X-ray product development)

  • In depth understanding of system wide IQ, combining IQ related theory (e.g. x-ray physics, image processing, visual perception, etc.) with understanding of relevant products and the application by the end-user.

  • Knowledge of relevant regulations (UL, CSA, IEC, ISO, MDD, CE, etc.) and relevant standards (General Safety, EMC, Radiation Safety, Risk Management, Environmental, Sustainability, etc.).

  • Knowledge on project organization, PCP and ISO 13485.

  • 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.

  • Analytical, creative and abstract thinker.

  • Ability to communicate (both written and verbal) on different levels.

  • Is 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

  • Excellent communication skills

  • Team player, leadership skills and drive for results

  • Mindset to simplify and reach to solutions with speed

  • Intercultural sensitivity

  • Self-motivation

In return, we offer you a challenging, innovative environment with great opportunities to explore. Our benefits are very competitive and designed around your preferences:

  • A rewarding career in Philips with attractive package. `

  • A variable bonus based on both Philips results and personal performance

  • Extensive set of tools to drive your career, such as a personal development budget, free training and coaching

  • Attractive collective health insurance package

  • Opportunity to buy Philips shares and products with discount

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .