Join Veltist: Shape the Future of Post-Operative Care
At Veltist, a Wyss Zurich project, we are revolutionizing post-operative care through our innovative platform technology, AnastoSeal. We aim to enable 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. As an in-foundation startup, we are built on a multi-year research and development effort focused on a novel class of implantable surgical materials.
Position Overview
We are seeking a Quality & Regulatory Affairs Specialist (QARA) to help us efficiently, safely, and successfully bring a Class III implantable device to the clinic. In this role, you will serve as a vital link among engineering, manufacturing, quality, and regulatory partners. The ideal candidate is scientifically minded, eager to understand how things work, able to connect various disciplines, and genuinely motivated to build a first-in-human dossier for an innovative medical implant.
With a solid foundation in translational science, we are entering an accelerated growth phase as we progress our technology toward first-in-human clinical trials while expanding our technical and regulatory capabilities.
Our Mission
At Veltist, we work at the intersection of materials science, engineering, clinical translation, and regulatory strategy. Our mission is to develop a transformative class of implantable biomaterials that enhances surgical outcomes in high-impact clinical settings.
We collaborate closely with surgeons, clinicians, and regulatory experts to ensure our innovations are technically robust and clinically viable for real-world applications. As we prepare for first-in-human readiness, regulatory affairs and quality assurance remain central to our progress.
Key Responsibilities
- 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 output into clear, compliant regulatory documentation.
- Contribute to submissions and communications with notified bodies and competent authorities.
- Maintain up-to-date knowledge of MDR, relevant ISO standards, and clinical/biological evaluation frameworks.
- Enhance and maintain the ISO 13485 electronic quality management system (EQMS).
- Facilitate smooth transitions from R&D to manufacturing by connecting 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 among stakeholders.
Qualifications
We are looking for candidates with the following qualifications:
- PhD in Chemistry, Biochemistry, Biomedical Engineering, Materials Science, or related Life Sciences fields.
- A strong interest in regulatory pathways and strategy, combined with scientific curiosity about implantable materials and surgical technologies.
- Excellent collaboration and communication skills across engineering, materials science, chemistry, manufacturing, and clinical teams.
- A structured, detail-oriented, and rigorous approach to quality and documentation.
- A genuine motivation to contribute to the first-in-human translation of an innovative implantable device.
- Availability for a 100% position in Zurich.
Preferred Qualifications
- 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.
What We Offer
- A competitive 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 dedicated to improving surgical care.
- Additional benefits per ETH Zurich employee policies.
Apply online using the form below. Only applications matching the job profile will be considered.
Application Process
We look forward to receiving your online application, which should include:
- CV
- Motivation letter
- List of key reference contacts (1-3)
For more information about Veltist, please visit our website. For questions regarding the position, please contact Dr. Alexandre Anthis at aanthis@ethz.ch (no applications).
Please note that pre-selection will be conducted by the responsible recruiters and not by artificial intelligence.