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Regulatory Affairs Specialist MDR, Galway
Client:
Location:
Galway, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
b1e1c6cf9cef
Job Views:
2
Posted:
20.03.2025
Expiry Date:
04.05.2025
Job Description:
Our client, a Galway-based multinational, is looking to hire a Regulatory Affairs Specialist MDR on an initial 12-month contract.
Responsibilities:
* Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections.
* 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 the earliest possible approvals of clinical trial applications.
Requirements:
* Requires a relevant degree and a minimum of 2 years of relevant experience.
* Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience.
* Excellent attention to detail.
* Strong communication and teamwork skills.
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