The Role PE Global are recruiting for a Regulatory Affairs Specialist for our medical device client based in Galway. This is a 12-month contract role. Hybrid working options. Job Responsibilities 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 labelling, 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) Contributes to the completion of project milestones. May have some involvement in cross functional assignments. Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Education & Experience Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Interested candidates should submit an updated CV. Please click the link below to apply, or alternatively send an up-to-date CV to ****Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland**** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: MS Office Suite MDR Reg Affairs Science Med Device control systems
