Regulatory Affairs Manager
CAREERWISE RECRUITMENT
WESTMEATH
A Regulatory Affairs Manager is required by CareerWise Recruitment for a Medical Devices company in the Midlands. Support the strategic Manufacturing group to prepare global submission and registration documents in support product transfer activities; complete risk management activities, transfer and maintain technical files/design dossiers for the transfer products. THE ROLE: * Complete the regulatory planning activities for the applicable strategic manufacturing projects. * Clearly communicate regulatory requirements for the strategic manufacturing projects to the project managers and program manager. * Participate in project meetings to ensure that the teams remain compliant with regulatory requirements during the planning, execution and closure of the projects. * Interface with various departments as applicable for the project to ensure all regulatory deliverables are achieved. * Transfer technical files to the assigned legal manufacturer and maintain the technical files once transferred. * Complete risk management and post market surveillance activities to support the technical files at the sending sites until the transfer activities are complete. * Attract, retain and develop people within the team. REQUIREMENTS: * Degree; desired four-year college degree in Science or Engineering disciplines. * 5-8 years medical device industry experience. * Technical writing expertise. * Extensive knowledge and understanding of US and international medical device regulations, standards and guidance documents. * Project Management skills and experience. 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.
1627 days ago