Norm Compliance Officer

Norm Compliance Officer IGT Systems

In this role, you will have the opportunity to make life better!

Be part of the Norm Compliance team, support the Norm Compliance activities and deliverables for IGT- systems with all relevant mandatory international and national regulations including MDR and Philips Healthcare processes.

Participate in a cross functional development team, representing the Norm Compliance team, develop and execute the standards and compliance plan.

When you choose to work at Philips you’ll work on life-changing projects; and contribute to innovative health technologies and solutions that improve billions of lives around the world

You will be responsible for:

• Defining, for products to be developed, the applicable standards and regulations such as e.g. IEC 60601 series, IEC 62304, IEC 62366-1, 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

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

• A bachelor’s degree or higher 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

Related to the standards in the medical domain, knowledge on the following standards is preferred:

• IEC60601-1 series including collateral- and X-ray related particular standards.

• IEC62304 and IEC62366-1

• EU MDR and 21CFR820

• Artificial intelligence related standards and regulations

Philips

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 return, we offer you:

For this project, you’ll work for Philips and become a contract or permanent employee of YACHT (a Randstad company). As a contractor at Philips you'll enjoy cutting-edge challenges and unexpected experiences that make you a more in-demand professional.

Why work on a project at Philips?

If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.