Senior Regulatory Affairs Specialist

CAREERWISE RECRUITMENT

GALWAY

A Senior Regulatory Affairs Specialist is required by CareerWise Recruitment for our Galway based client. 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 staffs 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. * 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. * Identify and develop best practices within the Regulatory Affairs department including continuous development initiatives (MOS/COS. REQUIREMENTS: * Bachelors Degree required. * Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. * Experience in Medical Device or Pharma is essential. * Experience or working with regulatory files for USA / EU. * Lead projects/programs on own initiative and filed them. * Experience working directly with FDA, and notified bodies in the Europe. * Experience working with Class III medical devices or DMS Drug master file. * Experience filing using the ECTS system. * You are experienced with Microsoft applications including Word, Excel, SharePoint, Teams, and knowledge of Adobe Acrobat, Data Management Systems are desirable. Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. 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.

1355 days ago