With many new projects emerging, we are looking for a talented Regulatory Affairs Engineer.
⭐️ Key Responsibilities
You will work within the Hardware development team and will be the key person responsible for all regulatory aspects of new and existing products. Working in close collaboration with the other teams (research, product development, quality, product management, marketing), your main tasks will be to :
More specifically, support the development teams throughout the life cycle of a product in the implementation of the standards applicable to the device, including:
🗂 You have at least 3 years of experience (including internship and work-study) in EU or US medical device certification, 510 (k) preparation and submission, Quality Systems under QSR, MDR or/and MDSAP,
You are used to working within a quality management system, you know how to interpret and facilitate the implementation of regulatory guidelines and are familiar with the standards applicable to medical devices,
You have experience in a start-up where you have built quality systems combining rigour, flexibility and simplicity,
🤸You are comfortable talking about women’s health issues, are not intimidated by the topics of pelvic floor health, the vagina, childbirth and female intimacy in general, and curious to learn more.
💪🏽 You are a feminist and believe in the right of every woman to have access to fun and effective health solutions,
🇬🇧 You speak and write excellent English; French as a working language is a plus
⭐ Benefits
Ces entreprises recrutent aussi au poste de “Regulatory and Compliance Consulting”.