Philips Regulatory Affairs Specialist 

Israel, Haifa District, Haifa 

572386822

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Your role:

• Regulatory Affairs representative for business unit Programs and assists with regulatory matters such as labeling, marketing, technical documents, and 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

• Guide 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 business unit product lines based on completion of localization and licensing.

You're the right fit if you have:

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

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

• Ability to communicate effectively with cross-functional teams

• Excellent English skills (written and oral)

• M.Sc. - an advantage

• Certified regulatory affairs professional- an advantage

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .