Regulatory Affairs - Tipperary

Hartley People

Tipperary, Kilkenny, Waterford

The Role. - Maintain continuous compliance with ISO’s and Quality Management systems for the EU and the US. - Assist with regulatory submissions. - Carry out preparation and closing activities associated with Inspections and audits. - Support Quality system and regulatory system improvements activities. - Maintain and Develop document control system. - New Product Development Projects and continuous improvement initiatives. - Carry out and communicate all regulatory affairs approvals. - Maintain IMB manufacturing licenses. - Carry out reviews and approval of artwork. The Person. - A minimum 3rd level qualification Diploma in Science, Pharmacy or related discipline is essential. - Minimum 1 year experience in a pharma or medical device industry. - Strong organizational skills. - Excellent attention to detail. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent. For immediate consideration please call Sara on 051-878813 or email your CV in response to this job posting. Hartley People also recruit for similar roles such as Quality Control Manager, Quality Control Technician, Quality Assurance Manager, Quality Assurance Technician, New Product Development Manger, Quality Systems Manager, New Product Development Co-ordinator, Supplier Assurance Manager.

2396 days ago