A Senior Regulatory Affairs Specialist is required by CareerWise Recruitment for our Galway based client. This is a 12 Month Contractor role with a HYBRID solution available. THE ROLE: Directs or performs coordination and preparation of document packages for regulatory submissions. Supports change control activities to support global approval and implementation of product and process changes Leads or compiles all materials required in submissions, license renewal and annual registrations Teams with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support. Works with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies. Recommends changes for labeling and internal documentation, reports for regulatory compliance Keeps abreast of regulatory procedures and changes. Supports review of internal procedures to ensure continuous compliance with all regulatory requirements. May have direct interaction with regulatory agencies on defined matters Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives REQUIREMENTS: Level 8 Honours Degree Science or Engineering bachelor's degree/master's - A Regulatory Affairs qualification is desirable, but not mandatory Minimum of 5 years of relevant experience, preferably with Class III devices. Regulatory experience in Medical Devices, Pharmaceuticals, Software in a medical device or similar regulated industry is required You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams You have strong technical knowledge. You are skilled in thinking critically and making sound decisions. Ability to comprehend principles of engineering, physiology, and medical device use. You collaborate with global cross functional teams and create alignment with team members. Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements May provide guidance, coaching and training to other employees within job area. You set high standards and drive accountability in the execution of your responsibilities, and you model ethical behavior Ability to effectively manage multiple projects and priorities. Has an excellent attention to detail and are results orientated Proven problem-solving skills with the ability to identify risks and escalate issues as appropriate Good initiative and team player 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: Senior Regulatory Affairs Reg Affairs Specialist Contractor Benefits: Work From Home
