Quality Regulatory Affairs Engineer

Careerwise Recruitment

Sligo

A Quality Regulatory Engineer is required by CareerWise Recruitment for our Sligo based client. If you are interested in Medical Devices, Production & Manufacturing, then this is the position. THE ROLE: * Review and approval of validation documentation (protocols & report. * Ensure the archiving and filing of validation documentation associated with the project. * Facilitate equipment FMEA and ensure, with the Program Manager, that the SME is trained to the FMEA process and updated on the relevant FMEA as required. * Drive the close out of change control, deviations, quality continuous improvement identified during the project. * Required to support department goals and continuous improvement initiatives. * Required to work as part of a project team to obtain the necessary information in support of these registrations. * Support the review and approval of Change Requests and actioning of International Requests. * May be required to communicate with external regulatory agencies (FDA, notified bodies etc) during the registration process. * May be required to interpret new Medical Device Regulations and develop internal procedure to ensure continuous compliance with all regulatory requirements. * Ready to provide adequate support to Project Team on any subject related to Regulatory Affairs. * Monitor and ensure compliance on site. * Train new staff on Regulatory processes as necessary. * Lead continuous improvements initiatives. * Team player to communicate and share good practices with QA dept. and other functions. * Identify key priorities of compliance requirements. * Lead process improvement projects within regulatory affairs. * Staying up to date with changing regulatory requirements expected. * Advising project/ development teams on regulatory needs. REQUIREMENTS: * Must have a minimum of 2 years' post graduate experience of working in a high-volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector. * 3rd level qualification, at a minimum to degree level, in Engineering/Quality/Science. * Applied understanding of QSR (21 CFR Part 820), Medical Device reporting (21 CFR Part 806), Enforcement Policy (21 CFR Part 7), ISO 13485, European Medical Device Directive. Please call Louise Mulligan today for further information on 094 900 3979 or email: lmulligan@careerwise.ie. CareerWise Recruitment - In Search of Excellence. CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Mayo ,Cork, Shannon, Galway and Dublin. This job originally appeared on RecruitIreland.com.

2356 days ago