Job TitleSr Norm Compliance Officer

Job Description

Sr Norm Compliance Officer

The Philips Healthcare Innovation Center (HIC), located in Pune, India, is pivotal in enabling Customer Innovation in healthcare for Philips across the globe. HIC is an innovation, end-to-end product development, and manufacturing facility for Philips, committed to patient safety and quality.

As a multi-business modality hub, HIC innovates across product lines, including Image-Guided Therapy (IGT), Precision Diagnosis, and Connected Care. Teams of R&D, design, software developers, mechatronics & product marketing work together to build a product starting from market requirement understanding until delivery. Products innovated and manufactured at HIC are launched/ shipped in both Indian and global markets.

HIC Pune is the global head-quarters for the IGT Mobile Surgery (MoS) business and it has a significant R&D presence for the Precision Diagnosis Cluster. The Philips portfolio of image-guided therapy solutions help innovate medical equipment  for advance minimally invasive surgeries with  sharp, detailed images.

Your role:

In this role, you have the opportunity to support the Norm Compliance activity for IGT-MoS products with all relevant mandatory international and national regulations including MDD & MDR and Philips Healthcare processes.

Own norm compliance portfolio for IGT MoS 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 RoadmapsBuild norm compliance team and coach them on various activities with the portfolio

You're the right fit if:

B Tech / 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 devicesKnowhow of design control processes for medical device designWorking knowledge of cabling design, design for EMI/EMC, Design for reliabilityGood 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 areaFast learner and interest to learn new technologies/business/systemsBe structured and self-organizedExcellent communication skillsTeam player, leadership skills and drive for resultsMindset to simplify and reach to solutions with speedIntercultural sensitivitySelf-motivation

How 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.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This role is an office-based role.

About Philips
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

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