Join Veltist – Transforming Post-Operative Care
At Veltist, a Wyss Zurich project, we are at the forefront of reshaping post-operative care through our innovative platform technology, AnastoSeal. Our aim is to develop the next generation of implantable biomaterials that facilitate sealing, healing, and integration with human tissue.
As a pioneering MedTech spin-off from the ETH Domain (ETH Zurich and Empa), and part of the Wyss Zurich Translational Center’s Portfolio Projects, Veltist is built on years of dedicated research and development, focusing on a novel class of implantable surgical materials.
Position Overview: Quality & Regulatory Affairs Specialist (QARA)
We are seeking a Quality & Regulatory Affairs Specialist (QARA) to assist us in the efficient, safe, and successful introduction of a Class III implantable device to the clinic. In this role, you will serve as a crucial bridge connecting engineering, manufacturing, quality assurance, and regulatory partners.
The ideal candidate will be scientifically minded, eager to grasp intricate details, capable of bridging multiple disciplines, and motivated to create a first-in-human dossier for an innovative medical implant.
Your Role
Regulatory Affairs Responsibilities
- Support the definition and execution of regulatory strategies for Class III implantable devices.
- Collaborate with experienced RA partners on technical documentation, biological evaluation plans, and first-in-human readiness.
- Translate engineering, chemistry, and manufacturing outputs into clear and compliant regulatory documentation.
- Contribute to submissions and interactions with notified bodies and regulatory authorities.
- Stay informed about the MDR, relevant ISO standards, and clinical/biological evaluation frameworks.
Quality Assurance Responsibilities
- Maintain and continuously improve the ISO 13485 electronic quality management system (EQMS).
- Facilitate seamless 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 completion.
- Coordinate with external quality and regulatory consultants to ensure alignment among all stakeholders.
Qualifications
- PhD in Chemistry, Biochemistry, Biomedical Engineering, Materials Science, or related Life Sciences fields.
- Strong interest in regulatory pathways and strategy, combined with a scientific curiosity about implantable materials and surgical technologies.
- Excellent collaboration and communication skills across engineering, materials science, manufacturing, and clinical teams.
- Detail-oriented and rigorous 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 such as 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 Qualifications
- Experience with implantable devices, biomaterials, or surgical technologies.
- Exposure to notified body interactions or regulatory submissions.
What We Offer
- A competitive salary package based on experience and fit.
- Equity participation (ESOP) based on contributions and seniority.
- A clear leadership growth path within a dynamic, high-impact startup environment.
- Access to exceptional resources across ETH Zurich, Wyss Zurich, Empa, and our 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 in accordance with ETH Zurich employee policies.
If you are interested in joining our team and contributing to our mission, apply online using the form below.
Only applications matching the job profile will be considered. Further information about Veltist can be found on our website. For questions regarding the position, please contact Dr. Alexandre Anthis at aanthis@ethz.ch (no applications).
Please note that the pre-selection is carried out by responsible recruiters and not by artificial intelligence.