Quality & Regulatory Affairs Specialist / Quality & Regulatory Affairs Specialist

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

80%-100%, Zurich, fixed-term

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 the 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 work, capable of bridging different disciplines, and sincerely motivated to build a first-in-human dossier for an innovative medical implant.

With a strong foundation in translational science, we are 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 develop a transformative class of implantable biomaterials aimed at improving 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 also 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 purposeful innovation and the power of strong collaboration to 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 and 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.
• Strong interest in regulatory pathways & strategy paired with scientific curiosity and motivation to understand implantable materials and surgical technologies.
• Ability to collaborate and communicate across engineering, materials science, 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

Veltist offers a dynamic and collaborative work environment that encourages innovation and team collaboration as we work towards improving surgical care.

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 culture that values curiosity, responsibility, and initiative.
• 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 environment in which the rights and dignity of all our staff and students are respected. Sustainability is a core principle for us; we are consistently striving 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 its excellent education and cutting-edge research, ETH Zurich fosters an environment that inspires excellence. Located in the heart of Europe, we collaborate globally to address today and tomorrow's challenges.