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Senior medical device regulatory compliance specialist

Cork
beBeeMedicalDevices
Compliance specialist
Posted: 26 January
Offer description

Quality Assurance Associate


Description:


This is an exciting opportunity to join a team that develops innovative medical devices. The Quality Assurance Associate will play a key role in maintaining the effectiveness of the Quality Management System and driving continuous improvements.



Responsibilities:



* Maintain the QMS, ensuring it meets regulatory requirements.

* Manage day-to-day QA activities, including supplier relationships and audits.

* Assist with notified body audits and internal audits.

* Cordinate quality system schedules, including supplier and internal audits, management review, and documentation updates.



(Simplified below for better readability))
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Athorough understanding of ISO 13485and EU MDR regulationsis essentialfor this position. If you have experiencein managingprojects within medical deviceorganizations,the ideal candidate profile includes:an engineering or sciencebackground,a proven track recordwith projectmanagement,Bachelor's degree in one of those fieldsalong withfour yearsexperience insimilar roles,you willbe well positionedto excel as our new QA associate!,

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