Ra Manager - Stent NPD

SIGMAR RECRUITMENT

GALWAY

Regulatory Affairs Manager. Start-up company with strong financial backing who are going to soon be entering a large phase of growth. Responsibilities: Develop the Regulatory strategy for new products and manage regulatory submissions to regulatory authorities and notified bodies. Compile regulatory documentation to support global pre and post market clinical studies. Provide regulatory oversight regarding customer complaints. Work cross functionally with R&D, Manufacturing and Quality Assurance departments. Ensure compliance to US Regulations, ISO 13485, MDD 93/42/EEC, MDR 2017/745 and other jurisdictions as required. Provide guidance for company employees regarding regulatory affairs. Review and approve product labelling changes, promotional literature and marketing materials prepared by the Company and its distributors. Provide input to regulatory aspects of design control, change control, non-conforming process. Supervision of regulatory team. Requirements: Bachelors or Masters’ degree with 7 years or more experience in regulatory affairs within medical device, preferable cardiovascular. Experience of working with the following standards: ISO 13485; ISO 14155; 21 CFR 820; 21 CFR 814; 21 CFR Parts 50, 54, 56, 812; MDD; EU MDR; ICH GCP. Quality management system experience. Experience of CAPA, Auditing and Risk Management (including FMECA. To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: jporter@sigmar.ie. All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

1589 days ago