A Senior Regulatory Affairs Specialist is required by CareerWise Recruitment for our multinational medical device client in Galway for a hybrid role on an initial 12-month contract.
The Senior Regulatory Affairs Specialist will lead the coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
THE ROLE: * Leads or compiles all materials required in submissions, license renewal and annual registrations.
* Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
* Monitors and improves tracking / control systems.
* Keeps abreast of regulatory procedures and changes.
* May direct interaction with regulatory agencies on defined matters.
* Recommends strategies for earliest possible approvals of clinical trials applications.
REQUIREMENTS: * Level 8 Honors Degree Science or Engineering bachelor's degree/master's * Minimum of 5 years of relevant experience, preferably with Class III devices.
* A Regulatory Affairs qualification is desirable, but not mandatory.
* Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements.
Please call Laura Gallagher today for further information on or email: CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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Skills: Senior Regulatory Affairs