Director Regulatory Affairs (60 – 100%)
Ava is a digital health company with the aim to revolutionize women’s health. The company is headquartered in Zurich, Switzerland with offices in San Francisco and partner offices in Belgrade and Makati. Our wearable device, smart app and proprietary predictive algorithms empower women by giving them unique clinically researched insights and personalized data about their menstrual cycle, fertile window, and pregnancy. All delivered in a way that’s convenient and non-invasive. Ava is a global, award-winning brand with strong social network communities. Our current key markets include USA, Canada, Germany, Switzerland, Spain and UK. Would you like to join us on our challenging adventure? We are looking for a highly motivate, entrepreneurial and pragmatic personality who enjoys working in a highly dynamic organization with global ambitions. In this key role for our organization, you will take the lead on all our regulatory affairs and truly move the needle in this space. Responsibilities: • Responsible to translate the CEO’s vision into global regulatory strategy and ensure and maintain compliance of products with all relevant regulations. • Liaise with competent authorities on strategies and submissions, especially US FDA. • Own preparation, submission and maintenance of regulatory dossiers globally. • Lead Post Market Surveillance and assessment of changes related to hardware, software, algorithm and labelling. • Depending on your profile the position may include the responsibility for quality management (“Director Regulatory Affairs and Quality Management”) About you: • Passion for Ava, our community, and our mission to bring women’s health to the 21st century • Master/PhD in natural science, medicine, engineering or equivalent from a renowned university • 8+ years experience in a similar role in the medical device industry. • In-depth knowledge of FDA regulatory pathways (510(k), de novo), CFR 21 Part 820, ISO 13485 and MDR as well as sound understanding of product development incl. clinical trials / GCP and how they affect the regulatory approval timeline in different territories • Direct experience with the US regulator e.g. pre-submission meetings, lead on 510(k), IDE or PMA submission/defiency responses • Experience with software as a medical device (SaMD) incl. firmware, apps, and cloud-based algorithms is a strong plus • Excellent communication, people and project management skills to lead the “approval journeys” • Ability to work independently in a fast-paced environment and to manage multiple, competing priorities; comfortable dealing with high pressure and regulatory uncertainties • Fluency in English; Other European languages are a plus • Swiss or EU/EFTA work permit Would you like to contribute to a highly motivated team, with a lot of space for your own initiatives? If yes, please apply online or send your complete application. We appreciate that you share our excitement for Ava. Please be aware that only fully documented applications (CV, motivation letter and supporting documents) can be considered.