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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.
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