Regulatory Compliance & Standards Office

ICDS RECRUITMENT

WATERFORD

REGULATORY COMPLIANCE & STANDARDS OFFICER - County Waterford. JOB DESCRIPTION: As Compliance & Standards Officer you will be responsible for compliance as required by 2017/745 MDR, lead standards compliance programs and product registration alignment activities. Key Responsibilities include but not limited to: • 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. Key Requirements for this role: • 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.

1617 days ago