Mission & Job description
Drive the quality and regulatory strategy of Neuroventis
Maintain the ISO certifications of the company (ISO13485, ISO27001), with the existing QA/RA team
Drive regulatory requirements from Europe to the US, to potentially other markets, on both medical device regulation and data privacy & security regulations (you will be assisted by the QA/RA team, as well as consultants where needed)
Work with the whole company to build an agile, yet highly qualitative and secure company system that is delivering impactful and qualitative software products
Be a leader in the quality and security policies of the company: ensure that the policy is understood, implemented and maintained at all levels of the organization.
Report to the management on the functioning and effectiveness of the quality management system.
Ensure the application of the quality system and conduct internal quality audits
Manage costs related to quality and registrations.
Drive the definition, implementation and evaluation of the company’s regulatory strategy to ensure the conformity of product(s) and facilities with the various regulations applicable in the different countries concerned.
Support the team in the development and commercialization of its products and services from a QA/RA perspective
Work with the QA/RA team, as well as the rest of the team
Help to manage communications with competent authorities and notified bodies.
Required skills, education & experience
Either a scientific master’s degree (law, medicine, pharmacy, engineering or another relevant scientific discipline) and at least 4 years of professional experience in regulatory affairs or quality assurance relating to medical devices; or 7 years of professional experience in regulatory affairs or quality assurance relating to medical devices.
Good knowledge of ISO13485 associated repositories.
Some ISO27001 knowledge is a plus.
Medical device software experience is a big plus.
Good knowledge of European regulatory framework for medical devices (EU/MDR).
Some FDA knowledge is a plus.
Soft skills: leadership, organization, teamwork, initiative.
Interest for the software world.
English at minimum but any additional language is an asset.
Quality oriented, rigorous mindset and ability to meet the deadlines.