We are looking for a Regulatory Affairs Engineer. You will be responsible for developping regulatory strategies to optimise the launch and commercialization of wellness and medical devices (Class I and II).

More specifically:
🛠️ Support the development teams throughout the life cycle of a product in the implementation of the standards applicable to the device,

📝 Develop and implement a regulatory strategy to find the shortest path to market,

🔍 Register with the FDA (and manage 510(k) submission if applicable), CE (under MDR), or any other regulatory authority, class I and II medical devices,

📊 Make sure that our products and labelling are compliant with the applicable standards and organize and follow up certification testing,

🔍 Maintain and streamline our quality system under QSR and MDR, and obtain MDSAP certification,

🕵️‍ Ensure regulatory monitoring,

💼 Be the PRRC (Person Responsible for Regulatory Compliance) according to EU MDR 2017/745 on Medical Devices.

💼 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 rigor, 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.

Advantages :
💰 Equity participation (BSPCE) for all employees after the end of the trial period,
🏥 Mutual with excellent health coverage (Alan),
🍱 Swile “restaurant tickets”, 60% covered by the company,
🏋️‍Free subscription to Classpass to take care of yourself and your health,
🏠 Places financed in company kindergarden,
🏢 A place where it is good to work in a friendly atmosphere, with spacious offices in the center of Paris.

• Entretien RH/Opé
• Case study
• Entretien Founder