Snr Regulatory Affairs Specialist
Sanderson Recruitment Ireland
Senior Regulatory Affairs Specialist. Responsibilities: A great opportunity to join a well established company where you would be contributing to impoving the lives of others as well as enjoying a great culture and work life balance. Dev. of data for EU MDD Class III Design for submission to maintain CE Technical Files aligned with device & process changes. Interpret new Medical Device Regulations & develop internal procedures to ensure compliance with all reg. requirements. Support reviews of Change Request impact on reg. filings, & update latter where applicable. Key member of the NPI , design control teams & site eng. projects to ensure device compliance to appropriate International Reg. requirements. Integral part of the Risk Mgt. team, supports maintenance of Risk Mgt. Files (MDHA, D-FMEA, P-FMEA etc) in line with real time PMS data, device & process changes. Support comms between eng depart. & third party electrical safety certifiers. Support assessment & closure of audit findings & related to reg. / QMS audits as needed. Assist QA in CAPA investigation & root cause analysis, & performance of effectiveness activities. Support dev. of reg. strategy for & execution of transition from the Medical Device Directive to the Medical Device Regulation. Qualifications: Third level qualification in an engineering or science discipline. At least 5 years' exp. in a RA role, or equivalent medical device (i.e. quality, engineering, etc.) within a CE marking, FDA & ISO 13485 regulated medical device . Exp. of EU Medical Device Directive, 21CFR820, 803 & 807, & ISO 13485 requirements. Exp. in internal audit ing for compliance to Medical Device QSRs is not required, but is an advantage. Great communication skills with mgt. & fellow peers, both in person & remotely. Please apply for a confidential discussion with Nicola. This job originally appeared on RecruitIreland.com.
70 days ago