Senior Regulatory Affairs Associate

Senior Regulatory Affairs Associate Medical Device West Lothian remote working available but hybrid preferred After an incredible 12 months of working towards FDA approval and opening overseas manufacturing sites, this Scottish born medical device company are going global due to demand for their product. As part of their growth, they are searching for an experienced regulatory professional with relevant medical device or similar experience. This role offers exposure to several regulatory areas. You will be working across global markets (US, UK, EU), and knowledge of changing EU legislation will be highly valuable. Their Regulatory Affairs Team underpin the whole business. As manufacturers of a high risk device, it is imperative that the safety and efficacy of the product is maintained. You will be joining an existing team of excellent professionals who truly act as the glue of the business For this reason, whilst remote working is available, some time on-site is preferred for road mapping, strategy planning and team bonding. We are happy to consider individual circumstances when discussing this. Some preferrable areas of experience : Preparation of technical documentation and submission of global regulatory filings Familiar with MDR, PMA applications and supplements Regulatory strategies for new products Requirements : BSc level in a technical or scientific discipline Experience within medical devices or diagnostics Knowledge of EU and international regulatory requirements Why Apply? A flexible working environment A strong salary and bonus package The chance to gain or continue your career exposure to global markets and advance your experience How to apply : Hit the 'Easy Apply' button on this post, or email dionentrustrs.com for a private discussion.