You are here: Jobs / Senior Regulatory Affairs Specialist @ Salvia BioElectronics
5656 AE Eindhoven
E: mb.info@salvianeuro.com
Language: English
Hours / week: 40
Salvia BioElectronics is a medical device company pioneering neuromodulation therapies for migraine. Salvia's unique, paper-thin implant is designed to reduce the frequency and intensity of migraine attacks by delivering gentle electrical pulses to the nerves associated with the condition. The company is currently in the clinical stage of development. In addition, Salvia is considering potential opportunities the device creates for the treatment of cluster headache and other neurological disorders. Salvia has received the Breakthrough Device Designation from the United States Food and Drug Administration (FDA), which facilitates expedited market access for devices that treat life-threatening or irreversibly debilitating conditions.
We offer a challenging position for a seasoned Regulatory Affairs Specialist. Reporting directly to Salvia’s Chief Medical Officer, you hold a key role as the regulatory expert in the cross-functional core-team responsible for the development and launch of our innovative medical device system. You consult with our international regulatory consultants to further refine Salvia’s global regulatory strategy. You liaise closely with R&D, clinical, market access, and quality to ensure compliance with regulatory and legal requirements for successful market authorization in the EU, USA, and other geographies. You are the primary contact with the Competent Authorities, Notified Body, EU expert panel, and FDA and you take ownership of writing and following up on FDA (Pre)Submissions, CE-mark dossiers, and other regulatory submissions.
mb.info@salvianeuro.com