Oliver Care is recruiting for a Senior/Regulatory Affairs Officer to join a medical device company based in Midlothian on a permanent basis.
Main responsibilities for this role include preparing, submitting and maintaining all product licence/registrations with the FDA, European notified bodies, Health Canada and other appropriate territories. As well as developing and maintaining product labelling requirement including liaising with external suppliers to manage labelling artwork revisions
To apply for this position you must have relevant experience within Regulatory Affairs in the manufacture of ICD diagnostic devices, biologics or medical device instrumentation. You should also have prepared and filing BLA, PMA and 510(K) submissions.