Quality & Regulatory Affairs Specialist / Quality & Regulatory Affairs Specialistess

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

80%-100%, Zurich, fixed-term

At Veltist, a project of Wyss Zurich, we are reshaping post-operative care through our innovative platform technology, AnastoSeal. Our aim is to develop the next generation of implantable biomaterials designed for sealing, healing, and integration with human tissue. Veltist is a pioneering MedTech spin-off from the ETH Domain (ETH Zurich and Empa) and is part of the Wyss Zurich Translational Center's portfolio projects. We are an in-foundation startup based on years of research and development focused on a novel class of implantable surgical materials.

We are seeking a Quality & Regulatory Affairs Specialist (QARA) to assist in efficiently, safely, and successfully bringing a Class III implantable device to the clinic. This role is critical in bridging engineering, manufacturing, quality, and regulatory partners. The ideal candidate is scientifically minded, possesses a strong desire to understand intricate details, and is motivated to create a first-in-human dossier for an innovative medical implant.

As we enter a phase of accelerated growth aimed at advancing our technology towards first-in-human clinical trials, we are expanding our technical and regulatory capabilities, bolstered by a strong foundation in translational science.

Project Background

Veltist operates at the intersection of materials science, engineering, clinical translation, and regulatory strategy. Our mission is to deliver a transformative class of implantable biomaterials that enhance surgical outcomes in high-impact clinical settings.

We collaborate closely with surgeons, clinicians, and regulatory experts to ensure that our innovations are technically sound, clinically meaningful, and feasible for real-world applications. As we prepare for first-in-human readiness, regulatory affairs and quality assurance are pivotal to our progress.

Joining Veltist means becoming part of a mission-oriented, interdisciplinary team committed to purposeful innovation and the belief that strong teamwork can drive real change in healthcare.

Job Description

Regulatory Affairs

• Support the definition and execution of the regulatory strategy for a Class III implantable device.
• Collaborate with senior regulatory partners on technical documentation, biological evaluation plans, and first-in-human readiness.
• Translate engineering, chemistry, and manufacturing outputs into clear, compliant regulatory documentation.
• Assist in 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.
• Strong interest in regulatory pathways & strategy, with a scientific curiosity about implantable materials and surgical technologies.
• Ability to collaborate and communicate effectively across engineering, materials science, chemistry, manufacturing, and clinical teams.
• Structured, detail-oriented, and rigorous approach to quality and documentation.
• Motivated to contribute to the 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

The workplace culture at Veltist is dynamic and collaborative, promoting curiosity and initiative within our mission-driven environment.

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 dedicated to improving surgical care.
• Additional benefits per ETH Zurich employee policies.

We Value Diversity and Sustainability

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 where the rights and dignity of all staff and students are respected. Sustainability is a core value for us as we work towards a climate-neutral future.

Curious? So Are We.

We look forward to receiving your online application using the form below.

Please note that only applications matching the job profile will be considered.

About ETH Zürich

ETH Zurich is one of the world's leading universities specializing in science and technology. Renowned for our excellent education, cutting-edge research, and direct transfer of new knowledge into society, we foster an environment that inspires excellence. Located in the heart of Europe, we connect with partners worldwide to develop solutions for today's and tomorrow's global challenges.