Regulatory Affairs Specialist (24 Month Contract)

CareerWise Recruitment

Longford

A Regulatory Affairs Specialist on a 24 Month Contract is required by CareerWise Recruitment for our County Longford based client. Please contact Tom Devaney for more information. THE ROLE: * Provide support for Regulatory Affairs related issues to ensure compliance with global regulatory requirements & Quality System regulations. * Execute and complete tasks and deliverables for CE marking activities as required according to IVD Directive. * Prepare and maintain Technical Documentation for Irish manufactured products. * Provide update and maintain status of product registrations and notifications. * Provide the required information including legal documentation for country specific Regulatory Affairs contacts to enable and maintain product submissions outside the EU as required. * Provide, as required, regulatory input and approval for changes and classification of changes to Device Master Records, Quality System records, labelling etc. * Perform regulatory risk assessments and provide approval for Customer and Quality Technical Communications. * Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well as the Corporate Global & Technical Standards. * Maintain ETMS To Do training list including those standards, Directives, and Regulations defined as relevant. REQUIREMENTS: * Level 8 Degree (Science or Technical) required. * 2-3 years experience in Regulatory, Technical or Quality areas within the devices or pharmaceutical industry. * Advanced organizational skills and attention to detail. * The ability to work co-operatively and effectively with others to establish and maintain good working relationships. * The highest levels of integrity in the successful completion of your work. * Excellent Communication Skills. Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, Life Sciences, ICT, Engineering, Food and Agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

1000 days ago