Senior Regulatory Affairs Specialist

Sigmar Recruitment

Galway

Senior Regulatory Affairs Specialist - Galway Ireland. About Your New Employer. Company is based in over 155+ countries, been present in Ireland since 1999. Technologies are used to treat nearly 40 medical conditions. Their therapies improve the lives of more than 2 people ever second.   About Your New Job. Teams with business unit Regulatory Affair Specialists and international regulatory colleagues to provide regulatory support for new products/therapies and changes to existing products. Recommends changes for labelling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance. Identify and develop best practices within the Regulatory Affairs department including continuous development initiatives (MOS/COS.   What Skills You Need. Bachelor’s degree required (Level 8. Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. Experience in Medical device and/or Pharma is essential. Works directly on regulatory files for USA / EU.  Experience working directly with FDA, notified bodies in the European Union and International Regulators preferred. Experience working with Class III medical devices.   Why Apply Through Sigmar? We’ll help manage your job hunt, strengthen your interview skills and tidy up your CV. We’ll provide you with an overview of the jobs market within your industry and help you tailor your jobs search. Gain access to exclusive roles that are not advertised elsewhere.   To apply for this position please contact Keeva O’Shea at Sigmar Recruitment T: +353 91 749264 E:    koshea@sigmar.ie. All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent.

935 days ago