Join Our Team at Veltist
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.
About the Position
We are seeking a Quality & Regulatory Affairs Specialist (QARA) to assist us in bringing a Class III implantable device to clinical practice efficiently and safely. In this role, you will act as a crucial link across engineering, manufacturing, quality, and regulatory partners. The ideal candidate possesses a scientific mindset, is eager to understand operational mechanisms, and can effectively communicate across various disciplines. A strong motivation to develop a first-in-human dossier for an innovative medical implant is essential.
Our Mission
At Veltist, we exist at the intersection of materials science, engineering, clinical translation, and regulatory strategy. Our mission is to introduce a transformative class of implantable biomaterials specifically designed to enhance surgical outcomes in high-impact clinical settings. We collaborate closely with surgeons, clinicians, and regulatory experts to ensure that our innovations are technically robust and clinically relevant as we prepare for first-in-human readiness.
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 and manufacturing outputs into clear and compliant regulatory documentation.
- Contribute to submissions and communications with notified bodies and competent authorities.
- Maintain up-to-date knowledge of EU MDR, relevant ISO standards, and clinical/biological evaluation frameworks.
- Contribute to and enhance the ISO 13485 electronic quality management system (EQMS).
- Facilitate seamless transitions from R&D to manufacturing by bridging various workflows.
- Support document control, change management, risk management, CAPA, and supplier qualification processes.
- Coordinate with external quality and regulatory consultants to ensure stakeholder alignment.
Qualifications
- PhD in Chemistry, Biochemistry, Biomedical Engineering, Materials Science, or related fields.
- Strong interest in regulatory pathways and strategy, along with a scientific curiosity to understand implantable materials and surgical technologies.
- Ability to collaborate and communicate effectively across diverse teams in engineering, materials science, and clinical domains.
- Detail-oriented with a structured approach to quality and documentation.
- Motivation to contribute to the first-in-human translation of an innovative implantable device.
- Availability for a full-time 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.
Desirable Characteristics
- Experience with implantable devices, biomaterials, or surgical technologies.
- Exposure to notified body interactions or regulatory submissions.
Benefits
- Salary package based on experience and fit.
- Equity participation (ESOP) based on contribution and seniority.
- Clear leadership growth path within a dynamic startup environment.
- Access to exceptional resources across ETH Zurich, Wyss Zurich, Empa, and clinical networks.
- A collaborative culture where curiosity, responsibility, and initiative are highly valued.
- A motivated, mission-driven team focused on advancing surgical care.
- Additional benefits as per ETH Zurich employee policies.
Application Process
We invite you to apply online using the form below. Only applications matching the job profile will be considered.
Learn More
For more information about Veltist, please visit our website. If you have questions regarding the position, please contact Dr. Alexandre Anthis at aanthis@ethz.ch (please do not send applications via email).
Please note that pre-selection is conducted by our responsible recruiters and not by artificial intelligence.