Cache of job #14159575

Job Title

Sr. Regulatory Affairs Specialist


CareerWise Recruitment




A Senior Regulatory Affairs Specialist is required by CareerWise Recruitment for our client based in Galway on a 12 Month Contract . This is a HYBRID ROLE . The mission is to develop innovative strategies for regulatory approval, anticipate and respond to changing regulatory requirements, and provide strategic leadership to influence the global regulatory environment to benefit the patients that are served. Regulatory Affairs is a key function within the business. Please contact Tom Devaney for more information. THE ROLE: * Directs or performs coordination and preparation of document packages for regulatory submissions. * Teams with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies. * Leads or compiles all materials required in submissions, license renewal and annual registrations. * Supports change control activities to support global approval and implementation of product and process changes. * Recommends changes for labeling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance. * Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements. * May direct interaction with regulatory agencies on defined matters. * Support 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 Science or Engineering Bachelor's Degree/Masters with a minimum of 4 years of relevant experience . A Regulatory Affairs qualification is desirable, but not mandatory. * Regulatory experience in Medical Devices and or Pharmaceuticals is required, and related relevant experience will also be considered. * 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. * You collaborate with others and create alignment with team members. * 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. * You are a good communicator and fluent in English, both in writing and speaking with strong organizational skills. Please call Tom Devaney today for further information on 091-758771 or email: CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, 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.

Date Added

48 days ago