Regulatory Affairs Specialist Mdr

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 earliest possible approvals of clinical trials 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 skills and teamwork skills.For more information and a confidential discussion on the role, please contact Michelle Mc Inerney. ****** 091 706717

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