Regulatory Affairs Lead
Description
We are seeking an experienced Regulatory Affairs professional to lead our regulatory strategy and ensure compliance with relevant regulations and standards.
* This includes developing and implementing a comprehensive regulatory plan, interacting with notified bodies, and maintaining the Design History File for Class III implantable devices.
Key Responsibilities:
* To support the creation & maintenance of product design & technical documentation in compliance with relevant regulations & standards (Class III, animal derived, implantable devices). This includes providing guidance to & coordinating inputs from the technical experts on each design project.
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