Senior Regulatory Affairs Specialist

1 week ago


Cheltenham UK, Gloucestershire, United Kingdom Selexa Biotech Full time

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…



  1. Responsible for improving and implementing QMS improvements and amendments
  2. Hands-on working knowledge of FDA/MHRA regulations and working with the appropriate notified bodies
  3. You will be the expert within FDA approvals; proven experience and fully conversant in FDA regulations and requirements for approvals
  4. Further experience of UKCA and CE marking, working cross functionally throughout the business to ensure the highest possible conformance
  5. Prior experience of completing 510k submissions
  6. 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…



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