Senior Standards Compliance Lead-

ICDS Recruitment

Waterford

Senior Standards Compliance Lead- Waterford. Principle accountabilities. •Manage standards compliance ,ensuring sites have up to date site standards lists in place. To provide support on any external investigations. •Drive alignment and harmonization of standards within sites and initiate QCRs where required to bring sites into compliance. •Field questions from competent authorities in regards to product performance and/or vigilance on the EU market and forward all correspondence to the legal manufacturer. •Conduct assessments of new product registrations to confirm correct product specifications. •Provide support to the Brexit and MDR projects for existing sites and ensure risks are assessed and mitigated. •Provide expertise in areas of interpretation wrt MDD 93/42/EEC, EU 2017/745, ISO 13485 & QSR. •Support audits & inspections (NB & FDA) of manufacturers, importers and distributors. •Provide expertise in regards to implementation of MDR 2017/745 & common specifications, contribute to discussions internally and with notified body. •Support EU MDR work streams e.g. economic operators, technical files, MDD renewals, quality systems. •Work on providing Brexit deliverables for Local RA submission e.g. CFS, DOC, CFG - approve artwork QCRs. •Provide PRRC support to the CL manufacturing and EU Authorised Representative. •Coordinate the participation in standards groups e.g. ISO. •Participate in local activities in Ireland e.g. HPRA meetings, NSAI, IMDA etc. •Deputise for the Compliance manager as required. •Attend key trade association meetings and conferences. Requirements. •Bachelor’s Degree BS in engineering or scientific discipline (Chemistry, Biology, Microbiology, Pharmacy or related technical field. •Experience in Regulatory Affairs or Quality Systems is desired. This job originally appeared on RecruitIreland.com.

2017 days ago