Regulatory Affairs Specialist Wexford

FRS RECRUITMENT

WEXFORD

My client is a multinational medical technology company focused on developing and delivering innovative solutions for patient care. They are seeking a Regulatory Affairs Specialist to join their team based in Wexford on a permanent contract. This is a fantastic opportunity to join a company who make a real difference to people's lives and work in the Sunny South Easy, easily commutable to Wexford Town, Waterford, Kilkenny and Carlow. What's in it for you? This is a superb opportunity to work in an RA Group for a multinational medical technology company. Working here will be a fantastic addition to your CV. Your work will truly make a difference to people's lives and you will work alongside cutting-edge technology and a world-class team. Perhaps you are based in the South East and commuting to Dublin or want to relocate to an area the attractive quality of life and cost of living in the area appeals to you. About the job: The Regulatory Affairs specialist will primarily be responsible for ensuring compliance to all relevant regulations which includes the maintaining all quality systems and related documentation. Responsibilities : Ensure continuous compliance with the following: FDA Quality System Regulation 21 CFR 820 (QSR. Medical Device Directive & Medical Device Regulation. Health Canada Medical Device Regulations. ISO13485 Medical Device Quality Management System ISO14971. Pertinent sections of the Japanese MHLW Ministerial Ordinance No. 169 and product related standards. All Internal Procedures. Assist with regulatory requests from customers and notified bodies, technical files etc.: Assist with preparation and closing activities associated with: oUnited States FDA inspections. oISO 13485 audits (see appendix 1 for details. oOther Regulatory Agency Audits. oInternal audits. Process customer notification and regulatory requests. Support Quality system and regulatory system improvements activities. About you: As the ideal candidate, you'll have: An Engineering or science degree or equivalent experience. 2-3 years experience in a QA/RA role within an FDA regulated environment - healthcare or medical device sector. Next Step: APPLY NOW or please email or call for more information on this amazing opportunity. You might also have searched for: RA job, RA Specialist job, Regulatory Specialist job, QA job.

1537 days ago