Join Our Team at Veltist
At Veltist, a pioneering Wyss Zurich project, we are revolutionizing post-operative care through our innovative platform technology, AnastoSeal. Our goal is to develop the next generation of implantable biomaterials that enhance sealing, healing, and integration with human tissue.
As a MedTech spin-off from the ETH Domain (ETH Zurich and Empa) and a proud part of the Wyss Zurich Translational Center’s Portfolio Projects, we are an emerging startup rooted in a comprehensive research and development effort focused on advanced implantable surgical materials.
About the Role
We are seeking a highly motivated Quality & Regulatory Affairs Specialist (QARA) to help us navigate the complexities of bringing a Class III implantable device to the clinic efficiently and safely. In this role, you will act as a bridge among engineering, manufacturing, quality, and regulatory teams. The perfect candidate is both scientifically curious and eager to learn about the intricacies of medical devices, demonstrating a strong commitment to creating a first-in-human dossier for our groundbreaking implant.
Our Mission
At Veltist, we stand at the crossroads of materials science, engineering, clinical translation, and regulatory strategy. Our mission is to spearhead a transformative class of implantable biomaterials aimed at enhancing surgical outcomes in high-impact clinical environments.
In collaboration with surgeons, clinicians, and regulatory experts, we ensure our innovations are not only technically sound but also clinically viable for real-world application. As we approach first-in-human readiness, regulatory affairs and quality assurance are foundational to our advancement.
Your Responsibilities
Regulatory Affairs
- Support the definition and execution of the regulatory strategy for a Class III implantable device.
- Collaborate with experienced RA partners on technical documentation, biological evaluation plans, and first-in-human preparation.
- Translate engineering, chemistry, and manufacturing outputs into clear and compliant regulatory documentation.
- Contribute to submissions and interactions with notified bodies and competent authorities.
- Maintain current knowledge of MDR, ISO standards, and clinical/biological evaluation frameworks.
Quality Assurance
- Maintain and continuously enhance the ISO 13485 electronic quality management system (EQMS).
- Facilitate seamless transitions from R&D to manufacturing by integrating 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 maintenance.
- Coordinate with external quality and regulatory consultants to ensure stakeholder alignment.
Qualifications
- PhD in Chemistry, Biochemistry, Biomedical Engineering, Materials Science, or a related field.
- Strong interest in regulatory pathways and strategy, paired with a scientific curiosity about implantable materials and surgical technologies.
- Proven ability to collaborate and communicate effectively across engineering, materials science, manufacturing, and clinical teams.
- Detail-oriented and methodical approach to quality and documentation.
- Desire to contribute to the first-in-human translation of an innovative medical device.
- Availability for a 100% position in Zurich.
Preferred Experience
- Experience in regulated environments (i.e., 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.
Additional Assets
- Experience with implantable devices, biomaterials, or surgical technologies.
- Exposure to notified body interactions or regulatory submissions.
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 enhancing surgical care.
- Additional benefits per ETH Zurich employee policies.
Apply online using the form below. Please note that only applications matching the job profile will be considered.
Contact Information
For further details about Veltist, please visit our website. Questions regarding the position can be directed to Dr. Alexandre Anthis at aanthis@ethz.ch (no applications).
We look forward to your online application.