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Philips Senior Regulatory Affairs Specialist in Israel - Remote Based, Israel

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In this role, you have the opportunity to

support and implement product regulatory plans, provide guidance on global regulatory strategy and product registrations, participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements and standards.

Position can be located at Haifa or Raanana

You are responsible for

  • Supporting the implementation of the Business’ long-range quality, regulatory and compliance policy

  • Creating Q&R awareness level as determined within the organization

  • Enforcing (a simplified) quality systems and harmonizing them across the Business

  • Introducing and implementing the quality processes and tools required to ensure product quality and customer satisfaction

  • Managing compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations

You are a part of

EDI (Enterprise Diagnostic Informatics) Q&R Organization. Our mission to improve the lives of 3 billion people per year by 2030. Every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. We enable our employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs. Our research and business provides unique opportunities to develop cutting-edge clinical solutions and deliver meaningful solutions in the healthcare space.

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

  • Relevant academic degree

  • Minimum of 5 years of similar work experience, in Medical Devices companies. Software Medical Devices companies – an advantage

  • Good understanding of the Quality System Regulation (ISO 9001 ISO 13485, 21 CFR Parts 803, 806 and 820)

  • Experience with business-related implementation projects, including being an active leader\contributor on projects with scheduled deliverables

  • English, communication – ability to interact and communicate in English, including demonstrable writing, speaking, and comprehension skills; ability to communicate across levels of the organization

In return, we offer you

Endless opportunities to learn and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already.

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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