Responsibilities:
• Ensure compliance with all relevant regulations in the US, Europe and other countries
• Develop and drive the global regulatory strategy
• Provide the necessary regulatory intelligence to support the clinical strategy – US, Europe and beyond
• Lead preparation, submission and maintenance of regulatory dossiers in the US and Europe
• Liaise with US FDA – direct experience with the US regulator is a requirement e.g. pre-submission meetings, lead on 510(k), IDE or PMA submission/defiency responses
• Experience with software as a medical device (SaMD) a strong plus
• Lead regulatory assessment of marketing claims and external communication
• Lead Post Market Surveillance; assess potential safety issues, determine whether a potential incident is
reportable to competent authorities as per the vigilance system
• Manage the assessment of changes related to hardware, software, algorithma and labelling associated regulatory submissions as appropriate
• Collaborate closely with key stakeholders incl. internal teams, consultants, and health authorities
• 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, computer science 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
• Experience with medical software incl. firmware, apps, and cloud-based algorithms is a strong plus
• Excellent communication, people and project management skills to lead the “approval journeys”
• Strong analytical skills to drive complex regulatory decisions in an area with a lot of regulatory uncertainties (wearable devices, apps, artificial intelligence, machine learning)
• Ability to work independently in a fast-paced environment and to manage multiple, competing priorities; comfortable dealing with high pressure at certain time periods
• Fluency in English; German and other European languages are a plus
• Motivation to work with advanced IT tools to make processes user-friendly and efficient
• Swiss or EU/EFTA work permit