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 the 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 Honor’s Degree in 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.
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