RESPONSABLE AFFAIRES RÉGLEMENTAIRES ET QUALITÉ / REGULATORY AFFAIRS & QUALITY LEAD

publiée le 20 / 10 / 2020

Société :

dianosic

Dianosic is a start-up that was  founded in July 2017. The company develops innovative solutions in the field of ENT, focusing specifically on intranasal bleeding and chronic sinusitis.

Ear Nose and Throat (ENT) conditions are the leading cause of physicians’ visits. Yet, there remains significant scope for improvement to meet medical reuqirements. DIANOSIC collaborates with healthcare professionals in order to provide solutions that change patient’s lives in both intranasal bleeding (epistaxis) and chronic sinusitis.

The company strives to:

  • discharge patients earlier from the hospital and reduce (re)hospitalization frequency
  • allow patients to return early to their everyday life activities
  • simplify care organization for healthcare professionals

More information regarding our startup and our technologies at : www.dianosic.com  

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). 

 

REGULATORY AFFAIRS & QUALITY LEAD key responsibilities include:

 

  • Define regulatory strategies for medical devices and combination products in EU and US for product submissions, identifying needs for bench, animal and clinical testing.
  • Ensure general RA/QA operational activities (e.g. regulatory watch, PMS, change control, NC/CAPA management etc..)
  • Participate on Product Development teams by providing regulatory strategy, timelines, and direction.
  • Comply with applicable EU and FDA regulatory laws/standards
  • Ensure continuous improvement of the organization through the maintenance of QMS efficiency. Ensure maintenance of ISO 13485 certification.

 

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Contact

Philippe Bastide, CEO (philippe.bastide@dianosic.com)
philippe.bastide@dianosic.com
0648035308