Quality & Regulatory Affairs Specialist / Quality & Regulatory Affairs Specialistess

Join Our Team at Veltist

At Veltist—a Wyss Zurich project—we are revolutionizing post-operative care through our innovative platform technology, AnastoSeal. Our mission is to enable the next generation of implantable biomaterials that enhance sealing, healing, and integration with human tissue.

As a pioneering MedTech spin-off from the ETH Domain (ETH Zurich and Empa), we are part of the Wyss Zurich Translational Center’s Portfolio Projects. Built on years of dedicated research and development, we focus on a novel class of implantable surgical materials.

Position Overview

We are currently seeking a Quality & Regulatory Affairs Specialist (QARA) who will play a crucial role in bringing a Class III implantable device to the clinic efficiently and safely. The ideal candidate will bridge the gap between engineering, manufacturing, quality assurance, and regulatory affairs. If you are scientifically minded, curious about how things work, and motivated to develop a first-in-human dossier for an innovative medical implant, we want to hear from you!

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.

Your Responsibilities

Regulatory Affairs

• Support the definition and execution of the regulatory strategy for a Class III implantable device.
• Collaborate with senior regulatory affairs partners on technical documentation, biological evaluation plans, and first-in-human readiness.
• Translate engineering, chemistry, and manufacturing outputs 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.

Qualifications

• PhD in Chemistry, Biochemistry, Biomedical Engineering, Materials Science, or related field.
• Strong interest in regulatory pathways and strategies, coupled with a scientific curiosity about implantable materials and surgical technologies.
• Ability to collaborate and communicate effectively with engineering, materials science, manufacturing, and clinical teams.
• Structured, detail-oriented, and rigorous in approach to quality and documentation.
• Motivated to contribute to the first-in-human translation of an innovative implantable device.
• Availability for a full-time position in Zurich.

Additional Desirable Experience

• 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 evaluations.

What 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 that values curiosity, responsibility, and initiative.
• A motivated, mission-driven team committed to improving surgical care.
• Additional benefits per ETH Zurich employee policies.

Application Process

Apply online using the form below. Only applications matching the job profile will be considered.

For further information about Veltist, please visit our website. If you have questions regarding the position, please reach out to Dr. Alexandre Anthis at aanthis@ethz.ch (no applications).

Please note that the pre-selection process is conducted by our responsible recruiters and not by artificial intelligence.