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Quality Management /Regulatory Affairs Champion (80-100%)

to join our team in Zurich-Schlieren, Switzerland

We are working on transforming patient lives with AveloCollect, our innovative non-invasive breath collector for pneumonia and Tuberculosis diagnosis. AveloCollect is the first non-invasive sampling device that captures pathogens from the lower respiratory tract for specific PCR detection. Are you eager to join a dynamic startup and use your quality management and regulatory expertise to make a tangible difference in global health, patient lives, and contribute to our market success? We are seeking a quality & regulatory champion who is eager to make every breath count. If that is you, we would love to hear from you!

Your Responsibilities

As a “hands-on-person” you will play a critical role in ensuring that our products meet the highest standards of quality and compliance. You will be responsible for developing and maintaining quality and regulatory systems that support our products, from development to market distribution. Your main tasks include:

  • Further develop, implement, maintain and continuously improve Avelo’s lean ISO13485 quality management system, ensuring compliance with applicable regulations and standards

  • Oversee regulatory affairs, including preparation of the technical documentation for regulatory submission, CE-marking and market registrations as well as post-market surveillance

  • Collaborate with a cross-functional team to drive quality and compliance initiatives across the organization

  • Oversee the quality control process (incoming & outgoing) and conduct internal and external audits to ensure adherence to quality and regulatory standards

  • Stay up-to-date with changes in regulations and standards, and communicate their impact to the organization

  • Inspire and motivate the team to live a lean, yet highly efficient and effective quality system

  • Be Avelo’s go-to person if it comes to ISO13485 and regulatory requirements, share your knowledge and train other team members

  • Manage projects and ensure project deliverables, budgets, quality targets and timelines are met. This includes projects as part of large international research grants in Europe and low-and middle income countries

  • Assume different roles and grow into new areas and/or leadership role as needed

Your Profile

As a “getting-stuff-done-person” you offer the full package including:

  • 3+ years of relevant experience in quality and regulatory affairs, with proven track record of establishing and maintaining ISO13485 quality management systems

  • 2+ years of relevant experience with regulated devices, ideally in vitro diagnostic (IVD) products within ISO13485 environment

  • PhD, MSc, BSc or significant experience in Medical Technology or Life Sciences or related degree

  • Strong knowledge of IVDR and related regulatory standards, experience with FDA processes and CLSI standards for IVDs is a strong plus

  • Proven experience in conducting audits and inspections

  • Experience with risk management, usability engineering, post market surveillance and clinical validation studies is a strong plus

  • Demonstrated ability to work effectively across multiple disciplines such as biology, material science and product management is desirable

  • Highly proactive and self-directed with strong attention-to-detail, integrity yet be willing to adapt processes as needed 

  • Hands-on team player with strong “can do” attitude, analysis and problem-solving skills who likes to multi-task, tackle challenges and improve own skills

  • Excellent written and oral communication skills in English and German

  • Applicants must be either Swiss citizens, EU nationals or have the legal right to live and work in Switzerland

We are looking for individuals from diverse backgrounds – what matters most is your passion to excel in our mission to transform breath-based diagnostics and thereby saving lives. In return, we offer a creative and flexible working environment where you can actively shape Avelo’s future and a chance to make a real difference for patients. Additionally, you will be able to participate in our stock option program to benefit from our success story. For more information on our values, please have a look at the About section on our website.

If you feel inspired and interested, we love to learn more about what drives you. Please send your application including CV, motivation letter and certificates to Melanie at

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