Philips Norm Compliance Officer 

India, Maharashtra 

840411325

Norm Compliance Officer

You are responsible for

• Own norm compliance portfolio for DXR products and execute end-to-end activities by 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 concerning technicalrealization/engineeringof norm compliance of the (sub) system.
• Support the verification (testing, witnessing reporting, and approval) of all specified legal requirements.
• Be the intermediary between development andcertifying/regulatoryagencies (UL/CSA/FDA/BSIetc).
• 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, updates, and execution.
• Contributing to Technology Roadmaps
• Build a norm compliance team and coach them on various activities with the portfolio

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

• Degree in bio-medical engineering having IQ specialization with ~12+ years of experience withminimum of 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 an 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 of 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 proactively.
• Analytical, creative, and abstract thinker.
• Ability to communicate (both written and verbal) on different levels.
• Is capable of introducing efficiency improvements on the project level (change management).
• System thinking mindset and domain expertise in the related area
• Fast learner and interested to learn newtechnologies/business/systems
• Be structured and self-organized
• Excellent communication skills
• Team player, leadership skills, and drive for results
• Mindset to simplify and reach solutions with speed
• Intercultural sensitivity

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

• A rewarding career in Philips with an 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 a discount