Senior RA Specialist - NEW

Cpl resources - County Offaly
30+ days ago

job description

Of this is to support department goals and continuous improvement initiatives, prepare and support vigilance on regulatory data related to the companys range of medical devices. Maintains site Regulatory Affairs compliance, based on cGMP per as defined in FDA 21CFR820, ISO 13485, MDD, CMDCAS, IEC 60601, and other International Regulations. As part of your role you will be a key member of the New Product Introduction, design control teams and site engineering projects to ensure device compliance to appropriate International Regulatory requirements. QUALIFICATIONS Third level qualification in an engineering or science discipline. EXPERIENCE REQUIRED At least 5-7 years 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 For further details please contact Tina on +353 1 278671 or email your CV directly to tdunne@thornshaw. Com

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