Regulatory Affairs Specialist

FRS Recruitment

Galway, Clare

Regulatory Affairs Officer. I am delighted to be assisting my global Medical Device company to source a Regulatory Affairs Specialist. In this role you will responsible for compilation of documentation and liaison with Corporate Reg Affairs & Subcommittees in respect of activities required for: adverse event review and agency reporting. issuing Product Information Notifications/Field Safety Notice/Product Corrective Action letters. Device modification proposals for review by Corporate RA. Compilation of global regulatory submissions. Co-ordination of the licenses for controlled substances and other documentation as required from the Dept. of Health & Children and Dept. of Agriculture. Implement regulatory/quality system requirements as per IVD Directive (CE Mark) ISO13485 and FDA QSRs. Control of distribution of product from regulatory perspective through regulatory stop ship program. Provision of Regulatory affairs advice when requested internally and from interpartners. Participation in company Internal and External Quality Audit as required. Involvement in Risk Management & Design Control processes from a regulatory perspective as required. Participation in Management Reviews of the Quality & Environment System as required. Communication to management on Regulatory affairs issues, which require addressing. Approval of Printed material from a regulatory affairs perspective. CE Marking - Regulatory requirements (ref. CE Technical Files. Dealing with European Competent Authorities as needed regarding vigilance and registration. Requirements. Will be qualified to a minimum of B.Sc. level in a Scientific field or other relevant technical field. Have a minimum of 1 year experience in a QA or RA role within a manufacturing facility. Excellent written and communication skills are essential, which will result in strong working relationships cross functionally within the company. Ability to work in a very busy environment, ability to manage change effectively in order to better serve our internal customers, external customers and legislative demands. Knowledge and understanding of the IVDD Directive and the associated harmonised standards. Knowledge and understanding of ISO13485: 2003 and the FDA QSRs. Experience of 510K preparation and submission process for FDA pre-market approvals is desirable. Experience of product registration process for countries other than EU and USA is desirable. Experience of internal auditing is desirable. Keywords: Regulatory Affairs Specilaist, Compliance Officer, quality assurance, Regulatory and Compliance Specialist,Regulatory and Compliance Officer,Reg Affairs. Contact Felicity in strict confidence on 086 7821714 for a more detailed discussion on this exciting role! This job originally appeared on RecruitIreland.com.

2788 days ago