Regulatory Affairs Lead
Regulatory Affairs Lead. Fast paced multinational medical device company whose Galway site primarily specialise in the design and manufacturing of guidewires. They have a fantastic flexitime policy with a fast-paced manufacturing environment which will give employees plenty of opportunities to progress and gain lots of experience as they grow. Responsibilities: Provide leadership for the site on any device design change. Complete submissions for CE Marking Registration, 510(k) registration and PMAs. Oversee the completion on technical dossiers, regulatory annual reports, supplements and registrations. Lead the regulatory preparation for the site for FDA, ISO13485, Customer and Corporate audits. Advise on certain customer complaints and investigations. Support queries coming from other sites or notified bodies. Answer customer regulatory requests and complaints. Support validation documentation programs. Review technical files for compliance to relevant medical device requirements. You will supervise the development of the QMS and change control process ensuring compliance to 21 CFR 820, MDR, MDD, ISO13485 and ISO14971. Requirements: Level 8 degree in engineering, science or relevant field. Must have 4 years previous experience in regulatory affairs. To apply for this position please contact James Porter at Sigmar RecruitmentT: +353 91 455305E: firstname.lastname@example.org. 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. This job originally appeared on RecruitIreland.com.
390 days ago