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 platform technology, AnastoSeal, which enables the next generation of implantable biomaterials for sealing, healing, and integration with human tissue. As a pioneering MedTech spin-off from the ETH Domain (ETH Zurich and Empa), we are part of the Wyss Zurich Translational Center's Portfolio Projects. Our startup is built on a multi-year research and development effort 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 application. In this role, you will serve as a vital link across engineering, manufacturing, quality, and regulatory partners. The ideal candidate should be scientifically minded, eager to understand complex systems, capable of collaborating across various disciplines, and sincerely driven to contribute to the development of a first-in-human dossier for an innovative medical implant.

With a strong foundation in translational science, we are entering a phase of accelerated growth as we advance our technology towards first-in-human clinical trials and expand our regulatory and technical capabilities.

Project Background

Veltist operates at the intersection of materials science, engineering, clinical translation, and regulatory strategy. Our mission is to introduce a transformative class of implantable biomaterials 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 both technically sound and clinically relevant for real-world applications. As we strive toward first-in-human readiness, regulatory affairs and quality assurance are fundamental to our success.

Joining Veltist means becoming part of a mission-driven, interdisciplinary team that believes in purposeful innovation and the power of collaboration to effect meaningful 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 readiness for first-in-human trials.
• Translate engineering, chemistry, and manufacturing outputs 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 smooth 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 the completeness of the design history file.
• 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 strategies, along with scientific curiosity about implantable materials and surgical technologies.
• Ability to collaboratively engage and communicate 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 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

We offer an inspiring work environment within an innovative startup, ripe for growth, collaboration, and impactful contributions.

We Offer

• Salary package commensurate with experience and fit.
• Equity participation (ESOP) based on contribution and seniority.
• A clear leadership growth path within a high-impact, rapidly evolving startup.
• 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 dedicated to improving surgical care.
• Additional benefits under ETH Zurich employee policies.

We Value Diversity and Sustainability

In line with our values, ETH Zurich fosters an inclusive culture that promotes equality of opportunity, values diversity, and nurtures a respectful working and learning environment. Visit our Equal Opportunities and Diversity website to learn about how we support a fair and open environment. Sustainability is a core value for us, and we are consistently working towards a climate-neutral future.

Curious? So Are We.

We look forward to receiving your application online using the form below. Please include the following documents:

• CV
• Motivation letter
• List of key reference contacts (1-3)

Only applications matching the job profile will be considered.

About ETH Zurich

ETH Zurich is one of the world’s leading universities specializing in science and technology. Renowned for our excellent education, cutting-edge research, and the direct transfer of knowledge into society, we have over 30,000 individuals from more than 120 countries. We promote independent thinking and foster an environment that inspires excellence. Located in the heart of Europe and connected worldwide, we develop solutions for the global challenges of today and tomorrow.