Quality & Regulatory Affairs Specialist / Quality & Regulatory Affairs Specialistess

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

80%-100%, Zurich, fixed-term

At Veltist, a Wyss Zurich project, we are reshaping post-operative care through our innovative platform technology AnastoSeal. Our mission is 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. We are a startup rooted in a multi-year research and development effort focused on developing a novel class of implantable surgical materials.

We are seeking a Quality & Regulatory Affairs Specialist (QARA) who will play a vital role in bringing a Class III implantable device to the clinic effectively and safely. This position serves as a bridge across engineering, manufacturing, quality, and regulatory partners. The ideal candidate will possess a strong scientific mindset, an eagerness to comprehend the intricacies of our work, and a genuine motivation to build a first-in-human dossier for an innovative medical implant.

With a robust foundation in translational science, we are entering an exciting phase of accelerated growth as we advance our technology toward first-in-human clinical trials and enhance our technical and regulatory capabilities.

Project Background

Veltist operates at the intersection of materials science, engineering, clinical translation, and regulatory strategy. Our aim is to introduce a transformative class of implantable biomaterials that enhance surgical outcomes in high-impact clinical settings.

We collaborate closely with surgeons, clinicians, and regulatory experts to ensure that our innovations are not only technically sound but also clinically meaningful and feasible for real-world application. As we approach first-in-human readiness, regulatory affairs and quality assurance become central pillars of our progress.

Joining Veltist means becoming part of a mission-oriented, interdisciplinary team dedicated to innovation with purpose and the belief in the power of strong collaboration to drive real 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 and highly experienced 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 interactions with notified bodies and competent authorities.
• Maintain up-to-date knowledge of MDR, relevant ISO standards, and clinical/biological evaluation frameworks.

Quality Assurance

• 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 completeness.
• Coordinate with external quality and regulatory consultants to ensure alignment across stakeholders.

Profile

• PhD in Chemistry, Biochemistry, Biomedical Engineering, Materials Science, or Life Sciences.
• Strong interest in regulatory pathways and strategy, combined with a scientific curiosity and motivation to understand implantable materials and surgical technologies.
• Ability to collaborate and communicate effectively across engineering, materials science, chemistry, manufacturing, and clinical teams.
• 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 full-time 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 foster a collaborative and empowering culture where curiosity, responsibility, and initiative are highly valued. Joining us means being part of a motivated, mission-driven team committed to improving surgical care.

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.
• Additional benefits consistent with ETH Zurich employee policies.

We Value Diversity and Sustainability

ETH Zurich promotes an inclusive culture, values diversity, and nurtures a working and learning environment that respects the rights and dignity of all staff and students. Sustainability is one of our core values, and we continuously strive toward a climate-neutral future.

Curious? So Are We.

Apply online using the form below. Only applications matching the job profile will be considered.

We look forward to receiving your application, including your CV, a motivation letter, and a list of key reference contacts (1-3).

Further information about Veltist can be found on our website. For questions regarding the position, please reach out to Dr. Alexandre Anthis at aanthis@ethz.ch (please do not send applications to this email).

About ETH Zürich

ETH Zurich is one of the world's leading universities specializing in science and technology. We are renowned for our excellent education, cutting-edge fundamental research, and the direct transfer of new knowledge into society. Over 30,000 individuals from more than 120 countries find our university to be a place that fosters independent thinking and inspires excellence. Located in the heart of Europe, we forge connections globally, working together to develop solutions for today's and tomorrow's global challenges.