Norm Compliance Officer

Job Title

Norm Compliance Officer

Job Description

Job title:

You are a part of the Ultrasound R&D team - Pune.

Philips HIC, Pune, is playing a key role in Philips' global strategy for Ultrasound. With Philips HIC, the foundation was laid to touch billions of lives and reiterate Philips' commitment towards Indian and growth healthcare markets.

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
• Self-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.
On-site 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.
Indicate if this role is an office/field/onsite role.
About Philips
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 our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
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 here.

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