QA/RA Supervisor. Location: Wexford. Salary: €65k + Healthcare for employee and family, pension (3% DC. Job Summary: Our client is seeking to hire an experienced QA/RA Supervisor to join their team. The ideal candidate will havestrong regulatory experience, Quality Systems experience, and supervisory experience. FDA is essential. The QA/RA Supervisor will be responsible for the development, maintenance, and distribution of quality documents within the Quality Management System ensuring compliance to relevant regulations, applying knowledge in the discipline of document management for the analysis and resolution of document management issues, including benchmarking against best practice and implementing innovative solutions. Accountabilities include: Supervision of the development, maintenance, and distribution of quality documents within the Quality Management System. This will cover: Management of the PMR system. Change Control Process. Documentation Control system for the QMS. Ensuring continuous compliance with the following: FDA Quality System Regulation 21 CFR 820 (QSR. Medical Device Directive. Health Canada Medical Device Regulations. ISO13485 Medical Device Quality Management System. ISO14971. Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standards. Any other applicable market regulation. Provide advice on regulatory affairs requirements for all proposed changes to device design. Compilation of regulatory submissions: PMAs, CE Mark registration, 510(k) registration, Technical Dossiers and similar applications and notifications. Annual reports, supplements and registrations. Leading the preparation and direct all activities for: FDA inspections. ISO 13485 surveillance audits. Corporate audits. Internal audits. Customer audits. Customer complaint investigation, reporting, closure and trending and follow through on close out of any subsequent actions assigned. Support our cilent's other sites with any queries relating to New Ross site that may arise during their audits. Review current technical product files for compliance to international requirements. Answer all customer regulatory requests and complaints. Act as regulatory affairs representative on product design and R&D redevelopment teams. Design and implementing quality systems improvements. Support plant validation documentation programs as required, ensuring records are maintained. SKILLS AND KNOWLEDGE: Degree or equivalent combination of education and experience. 3+ years configuration management/document control experience. 3+ years of prior supervisory or management experience. Competent in preparing written communication and correspondence. If you are interested in this role or know someone who might be suitable for this role, please contact Gavin Croghan at 01-6797766 firstname.lastname@example.org. This job originally appeared on RecruitIreland.com.
111 days ago