Senior Regulatory Affairs Specialist with Environmental

Selexa Biotech are exclusively partnered with a leading Medical Device manufacturer near Gloucestershire as we continue to develop and grow the QARA function.



A leader in medical device innovation and technology advancement within perfusion and Medical Device software for improved patient outcome.



The Senior RA Specialist role will be supporting a number of NPI projects, taking accountability and ownership of our clients Regulatory submissions, processes, complaints and driving QARA standards across the business…



* Responsible for improving and implementing QMS improvements and amendments



* Hands-on working knowledge of FDA/MHRA regulations and working with the appropriate notified bodies



* You will be the expert within FDA approvals; proven experience and fully conversant in FDA regulations and requirements for approvals



* Further experience of UKCA and CE marking, working cross functionally throughout the business to ensure the highest possible conformance



* Prior experience of completing 510k submissions



* Proficient working knowledge across ISO13485, ISO14971, SaMD, IS14001 – experience of creating, delivering and implementing an environmental management system is beneficial



Get in touch to discuss this excellent opportunity with a leading innovator