Quality & Regulatory Affairs Specialist (QARA) - Class III Medical Device

Quality & Regulatory Affairs Specialist (QARA) – Class III Medical Device At Veltist – a Wyss Zurich project – we are reshaping post-operative care through our platform technology AnastoSeal, enabling the next generation of implantable biomaterials for sealing, healing, and integration with human tissue. Veltist is a pioneering MedTech spin-off from the ETH Domain (ETH Zurich and Empa), currently part of the Wyss Zurich Translational Center’s Portfolio Projects. We are an in-foundation startup built on a multi-year research and development effort focused on a novel class of implantable surgical materials. We are looking for a Quality & Regulatory Affairs Specialist (QARA) who will help us bring a Class III implantable device efficiently, safely, and successfully to clinic. You will play a bridging role across engineering, manufacturing, quality, and regulatory partners. The ideal candidate is scientifically minded, eager to understand how things actually work, capable of bridging between different disciplines (both technically and humanly), and sincerely motivated to build a first-in-human dossier for an innovative medical implant. With a strong foundation in translational science, we are now entering a phase of accelerated growth as we advance our technology toward first-in-human clinical trials and expand our technical and regulatory capabilities. Project background Veltist exists at the intersection of materials science, engineering, clinical translation, and regulatory strategy. Our mission is to bring forward a transformative class of implantable biomaterials designed to improve surgical outcomes in high-impact clinical settings. We work closely with surgeons, clinicians, and regulatory experts to ensure that our innovations are not only technically sound but clinically meaningful and feasible for real-world use. As we approach first-in-human readiness, regulatory affairs and quality assurance are central pillars of our progress. Joining Veltist means becoming part of a mission-oriented, interdisciplinary team that believes in innovation with purpose and in the power of strong teams to drive real change in healthcare. Regulatory Affairs Support the definition and execution of the regulatory strategy for a Class III implantable device. Collaborate with senior and highly experienced RA partners on technical documentation, biological evaluation plans, and first-in-human readiness. Translate engineering, chemistry, and manufacturing output into clear, compliant regulatory documentation. Contribute to submissions and interactions with notified bodies and competent authorities. Maintain up-to-date knowledge of MDR, relevant ISO standards, and clinical/biological evaluation frameworks. Quality Assurance Maintain and continuously improve the ISO 13485 electronic quality management system (EQMS). Facilitate smooth transitions from R&D to manufacturing by bridging engineering, production, and quality workflows. Support document control, change management, risk management, CAPA, and supplier qualification processes. Contribute to verification/validation (V&V), biocompatibility testing, sterilization processes, and design history file completeness. Coordinate with external quality and regulatory consultants to ensure alignment across stakeholders. Profile PhD in Chemistry, Biochemistry, Biomedical Engineering, Materials Science, or Life Sciences at large. Strong interest in regulatory pathways & strategy paired with scientific curiosity and motivation to understand implantable materials, surgical technologies. Ability to collaborate and communicate across engineering, materials science - chemistry, manufacturing, and clinical teams. Structured, detail-oriented, and rigorous approach to quality and documentation. Motivation to contribute to first-in-human translation of an innovative implantable device. Availability for a 100% position in Zurich. Strong Pluses Experience in regulated environments (implants, GLP frameworks, clinical research, or controlled lab settings). 2–3+ years of QARA experience in medical devices or related fields. Familiarity with ISO 13485, MDR, design controls, and biological safety evaluation. Nice to Have Experience with implantable devices, biomaterials, or surgical technologies. Exposure to notified body interactions or regulatory submissions. Workplace We offer Salary package based on experience and fit. Equity participation (ESOP) based on contribution and seniority. A clear leadership growth path within a high-impact, fast-evolving startup. Access to exceptional resources across ETH Zurich, Wyss Zurich, Empa, and clinical networks. A collaborative and empowering culture where curiosity, responsibility, and initiative are valued. A motivated, mission-driven team committed to improving surgical care. Additional benefits per ETH Zurich employee policies. In line with our values , ETH Zurich encourages an inclusive culture. We promote equality of opportunity, value diversity and nurture a working and learning environment in which the rights and dignity of all our staff and students are respected. Visit our Equal Opportunities and Diversity website to find out how we ensure a fair and open environment that allows everyone to grow and flourish. Sustainability is a core value for us – we are consistently working towards a climate-neutral future. Curious? So are we. We look forward to receiving your online application with the following documents: CV list of key reference contacts (1-3) Please note that we exclusively accept applications submitted through our online application portal. Applications via email or postal services will not be considered. Further information about Veltst can be found on our website. Questions regarding the position should be directed to Dr. Alexandre Anthis, email aanthis@ethz.ch (no applications). We would like to point out that the pre-selection is carried out by the responsible recruiters and not by artificial intelligence. #J-18808-Ljbffr