A Principal Regulatory Affairs Specialist on a is required by CareerWise Recruitment for our Galway based client. Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. Advantageous to have: Pharmaceutical regulations, Pharmaceutical experience, Software in a Medical Device regulations and experience. Software as a Medical Device experience. STAMP 4 VISA a minimum requirement for this Contractor role. THE ROLE: * Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. * Leads or compiles all materials required in submissions, license renewal and annual registrations. * Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. * Monitors and improves tracking / control systems. * Keeps abreast of regulatory procedures and changes. * May direct interaction with regulatory agencies on defined matters. * Recommends strategies for earliest possible approvals of clinical trials applications. * Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. * May act as a mentor to colleagues or may direct the work of other lower level professionals. * The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). * Recognized expert, managing large projects or processes . * Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager . * Coaches, reviews and delegates work to lower level specialists. REQUIREMENTS: * Level 8 University Degree * Minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience. * Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. * May have broad knowledge of project management. Please call Tom Devaney today for further information on or email: 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. Skills: Regulatory Affairs Regulatory Affair Specialist Regulatory Affairs Principal
