Regulatory Compliance & Standards Office
Regulatory Compliance & Standards Officer. Key Purpose: As Compliance & Standards Officer the ideal candidate will be responsible for compliance as required by 2017/745 MDR, leading standards compliance programs and product registration alignment activities. Key Responsibilities. Standards management process. ISO13485 & MDSAP compliance. Project Management. SME supporting EU MDR implementation. Verification of product specification content in product registration. Set up and maintenance of a process for PRRC as per article 15 of MDR. Manage standards compliance and drive harmonisation for site ensuring site has up-to-date standards lists in place. Manage communication between competent authorised and/or notified bodies in regards to product performance and/or vigilance on EU market and forward all correspondence to the legal manufacturer. Conduct review and verification assessments of product registrations and/or renewals. Support projects as assigned EU MDR etc. Ensure risks are identified, assessed and mitigated. Support audits and inspections of manufacturers, importers and distributers. Co-ordinate and participate in standards group e.g.ISO. Participate in local activities in Ireland e.g. HPRA, NSAI, IMDA meetings. Support extended product portfolios as required. Minimum Qualification & Experience. 3rd level qualification in Quality, Regulatory, Engineering or another relevant scientific discipline. At least 4 years' professional experience in regulatory affairs or in quality management systems relating to medical devices. This job originally appeared on RecruitIreland.com.
31 days ago