Norm Compliance Officer jobs at Philips in India, Pune

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 new 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 verification (testing, witnessing, and reporting) and approval of all specified legal requirements.
• Supervise audits and witness testing performed with CSA personnel
• Maintain the current Philips Ultrasound certification program with CSA, as well as all business and working relationships with CSA.
• Be the intermediary between development and certifying/regulatory agencies (UL/CSA/FDA/BSI, etc).
• Train and inculcate design and cross-functional teams on regulatory standards, updates, and execution.

You're the right fit if:(4 x bullets max)

• B.Tech/ME/MTech in Bio-medical/Electrical/Electronics with 10+ years of experience, preferably in the Medical domain
• Knowledge and Experience of relevant regulations (UL, CSA, IEC, ISO, MDD, CE, etc.) and relevant standards (General Safety, EMC, Radiation Safety, Risk Management, Environmental, Sustainability, etc.)
• 5-6 years of work experience with product safety testing and EMI/EMC analysis
• Knowledge of IEC 60601 standards, risk management, verification, and validation of medical devices
• Know-how of design control processes for medical device design
• Knowledge of project organization, PCP, and ISO 13485 is preferred
• 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 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 solutions with speed
• Intercultural sensitivity

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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• Learn more about .
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 culture of impact with care .

Sr Norm Compliance Officer

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.

Your role:

In this role, you have the opportunity tosupport 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 technicalrealization/engineeringof 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 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, update and execution.
• Contributing to Technology Roadmaps
• Build 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 withminimum 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

How we work together

This role is an office-based role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .

Your role:

• Defining all applicable global product safety certification, product safety, EMC and environmental (if applicable) standards like IEC, EN, and ISO standards required to comply with all applicable international regulations.
• Define and review product requirements related to guidance, codes and standards to assure norm compliance and decomposition of standard requirements to the individual system or sub-systems.
• Preparation of norm compliance test plan that include applicable relevant clauses from standards (standards mainly include IEC60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-2-54, ISO 10993 etc.).
• Support in risk assessment related to product safety for achieving mitigation.
• Support usability and software teams to deliver documentation required for certification
• Support design and procurement team to ensure third party component level compliance
• Execute testing (witnessing, reporting and approval) of all specified product safety requirements.
• Arrangements of DXR product and required documents to test/certification agencies (like TUV/CSA/Any other lab) as part of submission and completion of certification activities.
• Support in preparing technical file deliverables (like GSPR and Compliance Data Record) in support to MDD, MDR, RED, REACH, RoHS regulations.
• Achieve certification of DXR products with all relevant global standards and regulations.
• Ensure timely delivery of all approbation activities / documentation adhering to Philips processes.
• Support the Regulatory team to achieve all regulatory approvals.
• Support all audits (FDA, Notified Body, INMETRO, etc).
• Review standard updates and provide standards gap assessment / technical support to the Regulatory team.
• Provide Training and guide all cross-functional teams on regulatory standards, update and execution.
• Maintain DXR compliance lab and its qualifications with CSA & Intertek as per ISO17025.
• Identification of approbation consequences due to change requests.
• Support factory inspections by certification agencies and address all audit observations in a timely manner (if applicable).
• Keep abreast of future upcoming regulatory & standards by interacting with notified body and standard organizations.

You're the right fit if:

• BE, BTech, ME, MTech degree (preferably in Biomedical/ Electrical/ Electronics/ Instrumentation).
• Minimum 10 to 15 years’ experience in product safety.
• Understanding of global mandatory / voluntary regulations like CE Marking, FDA, Health Canada, UL, CSA, INMETRO.
• Understanding of relevant standards (General Safety, EMC, Radiation Safety, Risk Management, Environmental, Sustainability, ISO17025, etc.).
• Knows how to participate in Design Reviews from norm compliance perspective
• Knowledge of regulatory submissions.
• Knowledge of X-ray systems will be an added advantage.
• Prior experience in product design will be preferrable.
• Excellent Communication skills.
• Understanding and implementation of good document practice (GDP).
• Strong hold on Compliance standards.
• Knowledge of Product safety and regulatory.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .
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 culture of impact with care .