Job Description

Job Title

Norm Compliance Manager

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow. But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most. The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs. In this role, you have the opportunity to make life better
Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all. In this role, you have the opportunity to lead Norm Compliance deliverables for Ultrasound products. Within the Project, ensure compliance with all applicable standards (IEC and others) for these products. Participate in a cross functional (medical) development team, representing the Norm Compliance team and develop and execute the standards and compliance plan You are responsible for

• 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 IEC60601-2-54
• Defining within the Standards and Compliance plan how the required standards and regulations will be covered into 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 with respect to 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 as preparation of submission to Regulatory bodies and countries
• Own norm compliance portfolio for Ultrasound 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 CSA, MDD & MRDR certification
• Definition of product requirements to assure norm-compliance
• Decomposition towards the individual (sub)system elements
• 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.
• 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, update and execution.

You are a part of 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.
To succeed in this role, you’ll need a customer-first attitude and the following

• BTech/ME/MTech in Bio-medical/Electrical/Electronics with 15+ yrs of experience, preferably in 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.)
• 5-7 years work experience with product safety testing and analysis
• Knowledge of IEC 60601 standards, risk management, verification and validation of medical devices
• Knowhow of design control processes for medical device design
• Knowledge on project organization, PCP and ISO 13485 is preferred
• 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 and dynamic assignment in an organization that continuously strives to develop its talent. You will contribute to our mission to improve people’s lives around the globe through meaningful innovation. We welcome you to a challenging, innovative environment with great opportunities for you to explore. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities. How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. 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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you. #LI-PHILIN