Job Description
Ratio Recruitment is working with our client, a well-known medical supply company to hire a Regulatory Affairs Specialistto join their team in County Offaly. As Regulatory Affairs Specialist,you willIdentify products compliant or not with regulatory requirements in our current markets and liaise with non-compliant potential suppliers. You will cover all regulatory aspects of the company and its requirements on a day to day basis. This is an exciting opportunity for an experienced candidate to further their career in a growing company. Our client is offering an excellent salary. This is a permanent position. Responsibilities: Manage Notified Body interactions. Manage the regulatory changes related to UKCA and MDR. Lead strategic quality improvement projects and initiatives which enhance the long-term sustainability of the company Maintain organized and up-to-date regulatory files, records, and documentation, ensuring accessibility and accuracy for internal and external stakeholders. Lead Management Review process; report on the performance of the Quality System Collaborate with cross-functional teams to assess and manage risks associated with products, processes, and regulatory changes. Implement risk mitigation strategies as needed. Qualifications/ Skills/ Experience: Qualification in Regulatory Affairs is essential. A minimum of 3 years experience in a medical device/healthcare industry in a regulatory position. Excellent verbal and written communication skills. Excellent attention to detail skills. Good understanding of ISO, MDD v MDR & CE/UKCA. Excellent attention to detail. If you are interested in this position, please apply with CV in Word format. Skills: regulatory affairs healthcare medical supplies Benefits: Medical Aid / Health Care Pension Fund