QA / Reg Affairs Supervisor
Careerwise Recruitment
Leinster, Wexford
A QA / Reg Affairs Supervisor is required by CareerWise Recruitment for our South-East based multinational Medical Devices client. Excellent opportunity to move onto the managerial pathway with a leading multinational. THE ROLE: The QA/RA Supervisor be responsible for the development, maintenance, and distribution of quality documents within the Quality Management System ensuring compliance to relevant regulations, applying knowledge in the discipline of document management for the analysis and resolution of document management issues, including benchmarking against best practice and implementing innovative solutions. Accountabilities include: * Supervision of the development, maintenance, and distribution of quality documents within the Quality Management System. This will cover Management of the PMR system, Change Control Process and the Documentation Control system for the QMS. * Ensuring continuous compliance with all applicable market regulation. * Provide advice on regulatory affairs requirements for all proposed changes to device design. * Compilation of regulatory submissions and annual reports, supplements and registrations. * Leading the preparation and direct all activities for audits. * Customer complaint investigation, reporting, closure and trending. REQUIREMENTS: * Degree or equivalent combination of education and experience. * 3 years configuration management/document control experience. * 3 years of prior supervisory or management experience. * Competent in preparing written communication and correspondence. * Ability to make verbal presentations. Please call Michael Hanrahan today for further information on 021-2019817 or email: mhanrahan@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. This job originally appeared on RecruitIreland.com.
1934 days ago