Norm Compliance Officer

1 month ago

Suzhou, China Philips Full time
Job TitleNorm Compliance Officer

Job Description

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 itâs not just what we do, itâs 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 customersâ needs. Itâs what inspires us to create meaningful solutions â the kind that make a real difference â when it matters most.

The world and our customersâ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. Thatâs 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 Philipsâ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, youâll be working towards creating a better and fairer future for all.

You are responsible for

  • Defining, for products to be developed, the applicable standards and regulations such as e.g. IEC 60601 series, IEC 62304, IEC 62366, the new EU MDR
  • Defining within the Standards and Compliance plan how the required standards and regulations will be covered into evidence for demonstrating compliance
  • Creating 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 IGT products
  • 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

You are a part of
the Norm Compliance team and support the Norm Compliance activities and deliverables for IGT- systems with all relevant mandatory international and national regulations including MDR and Philips Healthcare processes. The team is currently 12 people strong, operates as one scrum team and now also works on sustainability topics.

To succeed in this role, youâll need a customer-first attitude and the following

  • BSc/MSc degree in a technical field, health sciences or related
  • At least 3-5 years in Software and/or hardware Testing/Engineering or experience in similar roles within a complex environment
  • A background in the global medical devices industry would be considered a strong plus
  • Knowledge of product safety standards (e.g., IEC 60601) would be preferred
  • Familiarity with other national and international regulations is an advantage
  • Well-developed project management skills would be preferred
  • Proven experience in improvement activities and audits is an advantage
  • Team player that can influence environment for project success

In return, we offer you
We welcome you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences.

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 â 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 â 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. 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 everyoneâs 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 isnât 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. Itâs 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-EU

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