Description
My Client a critial care medical device company is seeking a Senior Regulatory Affairs Specialist to join their team in Offaly.As a Senior Regulatory Affairs Specialist, you will be a key member of our Regulatory Affairs group and required to demonstrate flexibility as priorities change. This role will initially involve 50 % travel to the UK.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
*Development of and collation of data for EU MDD Class III Design Dossiers for submission to Notified Body, maintains 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
*Integral part of the Risk Management team, maintains Risk Management Files (MDHA, D-FMEA, 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
*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.
EXPERIENCE/QUALIFICATIONS REQUIRED
*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
*50 travel to UK.
*Good planning and organizational abilities.
If you are interested in this great opportunity and have the relevant skills and experience please contact me Anna Mooney or apply below with an up to date CV.
To find out more about Real please visit www.realstaffing.com