Regulatory Affairs Specialist

ICDS Recruitment

Dublin South

Regulatory Affairs Specialist - South Dublin. Overview of Position: In this role you will be responsible in ensuring continuous compliance with regulatory standards. You will work closely with Quality, Operations and Sales and Marketing. As Regulatory Affairs Specialist you will be responsible for: • To ensure the company’s continuous compliance with the following regulatory standards: o The FDA Quality System Regulation 21 CFR 820 (QSR. o The In Vitro Diagnostic Medical Devices Directive 98/79/EC. o The Medical Devices Directive 93/42/EEC. o Health Canada Medical Devices Regulations. o ISO 13485 Quality Management Systems Requirements for Medical Devices. • Provide Regulatory advice & support to the company business units. • Liaise with all Professional & Regulatory bodies in the industry as appropriate on regulatory or legislative changes which impact on the company and to ensure effective implementation within the company. • Manage and co-ordinate all company vigilance/recall activities. • Provide guidance on worldwide regulatory requirements, providing regulatory strategies and co-ordinating during transfers, registrations. • Work as part of project teams in support of product registrations and liaison with customers and regulatory bodies during this process. • Create and maintain product technical files according to the IVD Directive 98/79/EC. • Act as Regulatory Affairs representative on the Design Control/Change Committee. • Responsible for maintaining awareness of the changing regulatory requirements. • Experience in UDI/GMDN environment is required. • Represent Regulatory Affairs at regulatory and customer audits. Skills and Behaviours sought: • Preferably 3 years' experience in a regulatory affairs role in the Medical Device/IVD industry. • Understanding of current regulatory standards. • Third level qualification in a science or related discipline or equivalent in terms of relevant operational experience. • Excellent organisational, planning and judgemental skills with excellent attention to detail. • Excellent analytical/decision making skills. • Ability to identify and drive regulatory compliance improvements. • Ability to work independently. • Have the ability to have a positive influence in a team based environment. • Excellent written and verbal and presentation skills. • Good working knowledge of Microsoft Excel, Word and PowerPoint. This job originally appeared on RecruitIreland.com.

2383 days ago