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Philips Quality and Regulatory Specialist in Eindhoven, Netherlands

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In this role, you have the opportunity to

Be part of a fast-growing business that help improve the lives of millions of people, while advancing Philips digital transformation journey as a global leader in Health Technology. You will help reach Philip’s ‘quadruple aim’: enhancing the patient experience, improving health outcomes, lowering the cost of care, and improving the work life of care providers. Cardiology Informatics develops software solutions which are at the heart of Philips innovative ambition and ‘quadruple aim’.

You are responsible for

  • Interpret standards and regulations and reflect these it the organizations Quality Management System (QMS)

  • Perform regular maintenance activities on the Quality Management system.

  • Define, develop and provide training against QMS

  • Maintain oversight and manage QMS changes needed.

  • Create Quality & Regulatory / QMS change management project plans and drive these to completion

  • Participate in and advice cross-functional project teams on application of the QMS, taking into account applicable regulations, requirements and standards.

  • Review (development) quality reports and plans to ensure they comply with the requirements of the QMS.

You are a part of

A highly innovative team, within an ever-changing environment - constantly striving for improvements, working according the latest software methodologies and exceeding internal and external stakeholder expectations. You will work as part of the Quality & Regulatory team of Cardiology Informatics

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

  • Bachelor/Master Degree in Informatics or other relevant science

  • 3-5 years of total industry experience with at least 2 years of experience in medical device (preferred) or in other regulated industries like pharma, automotive or aerospace (required)

  • Experience with dealing with software development (Agile, Safe) is preferred

  • Good knowledge and experience with Quality Assurance & control methodologies (requirement)

  • You have experience in Regulatory Affairs; interpreting regulations and standards and bringing these into practice

  • Excellent verbal and written communication skills in English

  • Working knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, FDA QSR, EU MDD

  • Experience in writing Quality Management System procedures.

  • Self-directed with a strong work ethic, with an ability to work in a goal-oriented environment

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. 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.

  • A market conform salary

  • 25 Days of leave and the possibility to purchase up to 20 extra days off annually

  • A variable bonus based on both Philips results and personal performance

  • Extensive set of tools to drive your career, such as a personal development budget, free training and coaching

  • Solid company pension scheme and attractive collective health insurance package

  • Opportunity to buy Philips shares and products with discount

  • Healthy work-life balance

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 improving 3 billion lives a year by delivering innovative solutions across the health continuum at https://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video at https://youtu.be/ocnMFp1JBuM .

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at https://www.careers.philips.com/professional/global/en/workingatphilips on our career website, where you can read stories from our employee blog at https://www.careers.philips.com/global/en/blog-unexpected . Once there,you can also learn about our recruitment process at https://www.careers.philips.com/global/en/recruitmentprocess , or find answers to some of the frequently asked questions at https://www.careers.philips.com/global/en/faq .

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