Quality & Regulatory Affairs Specialist / Quality & Regulatory Affairs Specialist

Quality & Regulatory Affairs Specialist (QARA) - Class III Medical Device

80%-100%, Zurich, fixed-term

At Veltist, a transformative Wyss Zurich project, we are revolutionizing post-operative care through our innovative platform technology, AnastoSeal. Our cutting-edge solutions are designed to enable the next generation of implantable biomaterials for optimal sealing, healing, and integration with human tissue.

As a pioneering MedTech spin-off from the ETH Domain (ETH Zurich and Empa), Veltist is part of the prestigious Wyss Zurich Translational Center's Portfolio Projects. We are a startup driven by years of dedicated research and development focused on a novel class of implantable surgical materials.

We are currently seeking a Quality & Regulatory Affairs Specialist (QARA) to assist us in efficiently, safely, and successfully bringing a Class III implantable device to clinical settings. In this pivotal role, you will collaborate across engineering, manufacturing, quality, and regulatory partners. The ideal candidate will be scientifically minded, possess a desire to understand intricate systems, and be capable of bridging diverse disciplines—both technically and interpersonally—while being genuinely motivated to develop a first-in-human dossier for a groundbreaking medical implant.

Project Background

Veltist operates at the crossroads of materials science, engineering, clinical translation, and regulatory strategy. Our mission is to advance a transformative class of implantable biomaterials aimed at improving surgical outcomes in high-impact clinical environments.

We work in close partnership with surgeons, clinicians, and regulatory experts, ensuring that our innovations are not only sound but also clinically relevant and practical for real-world usage. As we prepare for first-in-human readiness, regulatory affairs and quality assurance remain essential components of our progression.

Joining Veltist means being part of a mission-driven, multidisciplinary team that believes in purposeful innovation and the power of cohesive teams to effect significant change in healthcare.

Job Description

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 current knowledge of MDR, relevant ISO standards, and frameworks for clinical/biological evaluation.

Quality Assurance

• Maintain and continuously enhance the ISO 13485 electronic quality management system (EQMS).
• Facilitate smooth 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 the completeness of the design history file.
• Coordinate with external quality and regulatory consultants to ensure alignment among all stakeholders.

Profile

• PhD in Chemistry, Biochemistry, Biomedical Engineering, Materials Science, or Life Sciences.
• A strong interest in regulatory pathways and strategy, paired with a scientific curiosity about implantable materials and surgical technologies.
• Proven ability to collaborate and communicate across engineering, materials science, manufacturing, and clinical teams.
• A structured, 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 100% position in Zurich.

Strong Pluses

• 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.

Nice to Have

• Experience with implantable devices, biomaterials, or surgical technologies.
• Exposure to notified body interactions or regulatory submissions.

Workplace

At Veltist, we are dedicated to fostering an inclusive workplace culture that thrives on diversity and mutual respect. We believe that varying perspectives enhance our creativity and drive innovation.

We Offer

• A competitive salary package based on experience and fit.
• Equity participation (ESOP) reflecting contribution and seniority.
• A clear leadership growth path within a high-impact, fast-evolving startup environment.
• Access to exceptional resources across ETH Zurich, Wyss Zurich, Empa, and clinical networks.
• A collaborative culture that values curiosity, responsibility, and initiative.
• A motivated, mission-driven team committed to enhancing surgical care.
• Additional benefits in accordance with ETH Zurich employee policies.

We Value Diversity and Sustainability

Aligned with our values, ETH Zurich is committed to fostering an inclusive culture. We advocate for equality of opportunity, value diversity, and cultivate a working and learning environment where the rights and dignity of all staff and students are respected. Learn more about our Equal Opportunities and Diversity initiatives on our website. Sustainability is a core tenet for us; we are continuously striving toward a climate-neutral future.

Curious? So are We.

If you are interested in this opportunity, please apply online using the form below. Only applications matching the job profile will be considered.

To learn more about Veltist, visit our website. Questions regarding the position can be directed to Dr. Alexandre Anthis at aanthis@ethz.ch (please refrain from sending applications via email).

About ETH Zurich

ETH Zurich stands as one of the world's leading universities specializing in science and technology. We are known for our exceptional education, pioneering research, and seamless transfer of knowledge into society. With a diverse community of over 30,000 individuals from more than 120 countries, our university fosters independent thinking and an environment that inspires excellence. Located in the heart of Europe, we are connected globally, collaboratively seeking solutions for the challenges of today and tomorrow.