Quality Operations and Regulatory Affairs Specialist (Medical Device)

Entreprise : THERENVA

Référence : THEQORQS

Type de poste : CDI

Temps de travail : Temps plein

Salaire : à négocier

Salaire : MAster

Localisation : Rennes

À partir du : 17 novembre 2021

Publié il y a 2 semaines

Quality Operations and Regulatory Affairs Specialist (Medical Device)

Based in Rennes, France

Looking to join a dynamic and creative team to contribute to the design and adoption of computer-assisted surgery systems for the benefit of patients and healthcare professionals. Join Therenva! (https://www.therenva.com)

Therenva develops and markets an innovative cross-platform software in image processing for endovascular surgery applications – EndoSize. Distributed worldwide, EndoSize is a medical device software that enables vascular surgeons, cardiologists and implantable device manufacturers to provide optimal cardiovascular treatment to tens of thousands of patients each year.

Therenva also develops EndoNaut, a navigation station for aortic and lower extremity endovascular procedures. This 3D guidance system is a unique tool which assists the practitioner and secures the interventional procedure in the operating room by providing relevant information extracted in the preoperative phase. This information is rendered in augmented reality using artificial intelligence and numerical simulation algorithms.

Job Description

Main responsibilities/Job expectations

  • Establishes and maintains the Technical Documentation for Medical Devices with the support of other functions
  • Supports the different teams within the enterprise in the application of the risk-based approach
  • Monitors regulatory watch, communicates, and applies changes as required
  • Participates in internal and external audits
  • Supports product registration including document management
  • Provides necessary support the Medical Device team in approval and document reviews
  • Ensures that the processes necessary for quality management are established, implemented, and maintained
  • Reports to management on the operation of the quality management system and any need for improvement
  • Other Regulatory Affairs and Quality Operations duties, as required, to ensure ongoing compliance with the different requirements of the company

Professional Relationships

Activity implies close collaboration with all internal teams and occasionally with suppliers, customers, partners, regulatory bodies.

Profile

  • Master’s degree or equivalent in Quality, Regulatory Affairs or Engineering
  • Ideally experienced in Regulatory Affairs or Quality Management for Medical Devices
  • Knowledge of ISO 13485 or ISO 9001 standards and regulations relating to medical devices
  • Ability to effectively communicate (oral and written in English and French) and collaborate with internal and external stakeholders on an international and virtual base
  • Proficiency in Microsoft Office applications, comfortable with agile collaboration tools (wiki, Jira/Confluence…)
  • Analytical and synthesis skills
  • Motivational and interpersonal skills