Regulatory Affairs Specialist
CAREERWISE RECRUITMENT
GALWAY
A Regulatory Affairs Specialist is required by CareerWise Recruitment for our Galway based client. Plan, organize and implement strategies and activities required to ensure compliance to all US, EU and Company international requirements and corporate policies and procedures. THE ROLE: * Manages FDA regulatory submission process, including authoring submissions. * Oversees the development of dossiers for registration of products in countries outside the U.S, including authoring submissions. * Provides ongoing input to value improvement engineering teams on possible regulatory impact of proposed changes. * Applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization. * Establish and maintain regulatory information systems both electronically and hard copy. REQUIREMENTS: * Bachelor's Degree (4-year university degree) life sciences, technical (engineering), quality or related field. * 3 years' experience in a regulatory position. Regulatory background should include the medical device area. Please call Lisa Casserly today for further information on 091-339136 or email: lcasserly@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the 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.
1590 days ago