Regulatory Affairs Specialist

COLLINS MCNICHOLAS RECRUITMENT

OFFALY

My client, a well-established company in the healthcare industry, is looking to hire a Regulatory Affairs Specialist to join their growing company. This is a new and exciting role ! The ideal candidate will have 1+ years of experience in regulatory affairs, quality or documentation and will have a relevant qualification in science, engineering or quality. Responsibilities: (full job description available on request) Create and maintain audit friendly product file for customers and HPRA assurance. Analysis of product compliant or non-compliance with regulatory requirements. Research of alternative EU based suppliers. Evaluate changes to manufacturing and supply chain processes. Approve product labels, package inserts and marketing material. Requirements: A minimum of a degree in a Quality/Engineering/Science or related discipline is a MUST. At least 1 years’ experience in a medical device/healthcare industry in a regulatory or quality position. Must have very strong Technical Writing ability. Must have good understanding of ISO 13485 and FDA QSR quality standards. Excellent verbal and written communication skills. Excellent attention to detail skills. Must have the ability to work on own initiative, be able to work to targets and also as part of a team. For a confidential discussion and more information on the role, please contact Niamh Cregg. 071-9149732. niamh.cregg@collinsmcnicholas.ie. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs!.

1397 days ago