Medical Device - Regulatory Affairs Specialist, Scotland

Entrust Resource Solutions are currently supporting our Central Scotland based client to recruit an experienced Regulatory Affairs Specialist to join a rapidly growing IVD Medical Device organisation. This individual will report directly to the Quality and Regulatory Director and will be responsible for the regulatory activities for all manufactured products associated with their IVD medical device, including, assays, instruments, and software. It is essential that you have experience of working within RA, post market launch to the appropriate IVD quality and regulatory standards; ISO 13485, ISO 14971, FDA 21CFR part 820, IVD 98/79/EEC/IVDR. That you have experience developing and authoring CE marking technical files. Moreover, you must be knowledgeable and experienced with IVD risk management activities, adverse event and incident reporting (FSCA). You will show up as an excellent problem solver, who excels in communication across multi-levels and who can influence internal project teams as well as external regulatory bodies and third parties to maximise success