Regulatory Affairs and Quality Lead

publiée le 20 / 04 / 2021

Société :


DIANOSIC, is a Medtech start-up founded in July 2017. DIANOSIC develops innovative solutions in the field of ENT (Ear, Nose & Throat) to address significant unmet clinical needs. More specifically, DIANOSIC targets chronic rhinitis, chronic sinusitis and intranasal bleeding (epistaxis), which are very common conditions that
dramatically impair patients quality of life and have a major budget impact for the healthcare system and the society as a whole (sinusitis being amongst the top 10 most costly diseases for employers).


Descriptif du poste :

The Regulatory Affairs Lead (EU/US) will lead and be responsible for managing internal and external aspects of regulatory affairs for medical devices and combination products, including compliance of the QMS with ISO 13485 standard. The individual will develop the regulatory strategy for the company solutions by interfacing with DIANOSIC’s R&D partners, consultants and team members as well as with regulatory bodies (EU notified body, EMA, FDA, etc).

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