Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist - County Offaly. In this role you will act as a key member of the Regulatory Affairs group and will be required to demonstrate flexibility as priorities change. Key aspect of this position is to support department goals and continuous improvement initiatives, prepare and support vigilance on regulatory data related to the company’s range of medical devices. Maintain site Regulatory Affairs compliance, based on cGMP per requirements as defined in FDA 21CFR820, ISO 13485, MDD, CMDCAS, IEC 60601, and other International Regulations. CORE DUTIES AND RESPONSIBILITIES: • Development of and collation of data for EU MDD Class III Design Dossiers for submission to Notified Body, maintain currency of CE Technical Files aligned with device and process changes. • Interpret new Medical Device Regulations and develop internal procedures to ensure continuous compliance with all regulatory requirements. • Support reviews of Change Request Notes for change impact on regulatory filings, and update latter where applicable. • Key member of the New Product Introduction, design control teams and site engineering projects to ensure device compliance to appropriate International Regulatory requirements. • Integral part of the Risk Management team, maintain Risk Management Files (MDHA, DFMEA, P-FMEA etc) in line with real time PMS data, device and process changes. • Maintains, updates and submits change data to UL and CSA for device file updates. • Assists in preparation of regulatory submissions to FDA 510(k), LAPAC and other International Regulatory agencies. • Communicate with Notified Body, Competent Authority, and international regulatory authorities regarding license applications, CoFS updates, and vigilance and compliance issues. • Performs regulatory review of product labelling, provides P-MAP review of device promotional literature. • Perform vigilance reporting and other Agency complaint trending for devices, and develop necessary solutions to mitigate against repeats, and improve process. • Reads related regulatory publications and documents to stay informed about current regulatory actions that may impact owned devices. • Participates in and assists with FDA facility inspections, Notified Body Audits and other governmental inspections as directed. • Support audit findings or other actions related to regulatory / QMS audits as needed. • Assist QA in CAPA investigation and root cause analysis, and performance of effectiveness activities. Interested applicants should have: Third level qualification in an engineering or science discipline. At least 5-7 year’s experience in an RA role within an FDA and / or ISO 13485 regulated medical device environment. Demonstrable knowledge of 21CFR820, 803 and 807, and ISO 13485 requirements. Experience in internal auditing for compliance to Medical Device QSRs an advantage. • Good planning and organizational abilities. • Must have the ability to communicate effectively with management and fellow peers. • Pro-active with proven ability to work under own initiative, and strong team player. This job originally appeared on RecruitIreland.com.
188 days ago