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 .