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olutions across the <a href="https://www.philips.com/b-dam/corporate/corporateblog/2016/Philips_Chronic_Disease_5.jpg" target="_blank">health continuum </a>. Our people experie
some of the <a href="https://www.careers.philips.com/global/en/faq" target="_blank">frequently asked questions </a>. </p><p>#LI-EU </p></body></html>
al level, visit the <a href="https://www.careers.philips.com/professional/global/en/workingatphilips" target="_blank">Working at Philips page </a> on our career websi
ad stories from our <a href="https://www.careers.philips.com/global/en/blog" target="_blank">employee blog </a>. Once there,you can
ways. Learn more by <a href="https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.youtube.com%2Fwatch%3Fv%3DSjsIRScenFg%26feature%3Dyoutu.be&data=02%7C01%7C%7C2e6ce27a447d492df73708d75d39b5e2%7C1a407a2d76754d178692b3ac285306e4%7C0%7C0%7C637080374748362775&sdata=TafLfASqXFFV8BfOyCLajnNAUVmElZ5pjraYLrl%2FOjc%3D&reserved=0" target="_blank">watching this video </a>. </p><p></p><p></p><p>To find out m

Job Information

Philips Senior Regulatory Affairs Specialist in Haifa, Israel

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In this role, you have the opportunity to

provide regulatory guidance for DI product lines and work directly with cross functional teams to support global product market clearances.

You are responsible for

  • Regulatory Affairs representative for DI Programs, assists with regulatory matters such as labeling, marketing, technical documents, regulatory design change assessment required in the Development Life Cycle

  • Support the cross functional teams with regulatory guidance during all design control phases of a new product, major and/or minor changes

  • Directly responsible for the coordination and preparation of document packages to support global submissions and regulatory activities, including US, EU and Canada [510(k) Pre-market Notifications, PMAs, Product Reports/Supplements, GUDID (UDI), Technical Files, Declarations of Conformity, international Medical Device Licenses

  • Provide guidance on global compliance, such as CE Marking and product registrations, clinical evaluations, Canada Medical Device Regulations, etc.

  • Support in external audits (e.g FDA, CFDA, KFDA, PMDA, Notified Bodies) for Regulatory Affairs matters

  • Serves as local regulatory interface between the markets and the BIU site

  • Serves as local regulatory interface for the global business RA team

  • Maintains Product Shipment Authorization for DI product lines based on completion of localization and licensing

You are a part of

Q&R Organization within CT/AMI organization.

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

  • Relevant academic degree, B.Sc in engineering and/or life science is preferable

  • +5 years of experience in regulated environment, medical device background – a must

  • Knowledge of the relevant global regulations for successful preparation and submission of 510(k), PMA, TF and international registrations worldwide

  • Experience in supporting international registrations

  • Excellent English skills (written and oral)

  • Ability to communicate effectively with cross functional teams

  • Certified regulatory affairs professional – an advantage

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 . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there,you can also learn about our recruitment process , or find answers to some of the frequently asked questions .

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