Wyss Zurich Quality and Regulatory Affairs Manager 100 % The Wyss Zurich Translational Center is a joint accelerator of the University of Zurich and ETH Zurich (Swiss Federal Institute of Technology Zurich), which was made possible by a generous donation from the Swiss entrepreneur and philanthropist Dr. h.c. mult. Hansjörg Wyss. It was established to foster translational research focused on developing treatment protocols and clinical therapies, as well as novel technologies and intelligent systems, in the emerging fields of Regenerative Medicine and Robotics, and hybrid technologies thereof. Wyss Zurich unites world-leading experts from both institutions in multidisciplinary teams, pooling their knowledge and expertise. The Project LifeMatrix develops and manufactures tissue-engineered human matrices to repair and regenerate the heart. A multidisciplinary team from Wyss Zurich Translational Center has developed a unique tissue engineering technology to grow replacement tissue in the laboratory, which will be compatible with every patient, regenerate and grow with the recipient. To create this tissue, cells of human origin are first grown in culture on a scaffold in the shape of a heart valve or blood vessel. In a process called decellularization, the cells are then removed, leaving behind a perfectly shaped, biologically neutral human tissue matrix called LifeMatrix. After implantation, the recipient's own cells will repopulate the LifeMatrix, replacing the biodegradable scaffold; and this tissue will continue to grow with the child. Such grafts will avoid repeated major surgery and its associated risks. Previous work on autologous and personalized cellular tissues (patient receives tissue grown from his own body), which already obtained approval for a pilot clinical study by the German authority (PEI), is the basis for this next-generation tissue engineering technology. The Wyss Zurich Translational Center project aims to bring the LifeMatrix technology into the clinic with a first-in-human clinical trial. Your responsibilities Responsible for the compliance of all project activities with the internal quality management systems Responsible for supplier quality management, including supplier audits. Responsible for product development in the project and compliance with regulatory/legal requirements for product development. Performs the required activities (e. g. create rationales, decision finding, protocols) and generates the appropriate documents to ensure compliance with national and international regulations related to medical devices (FDA, ISO 13485) Plans and ensures the execution of all development activities, especially design verification and validation, including usability validation according to the internal quality management processes. Ensures that the design history file (DHF) is created and maintained Review of all the project DHF documents. Responsible for the completeness and filing of the project DHF documents. Release of the required project DHF documents. Review and release of the relevant lot and batch records. Coordinates the risk management activities with the process owner. Coordinates all development activities in cooperation with the line manager and the process owners as appropriate. Member of the Design Review Team Collaboration in continuous improvement activities, including reporting deviations and suggestions for improvement Collaboration and quality support for the relevant manufacturing activities, ensuring compliance with GMPs. Supports the needs of manufacturing areas in terms of meeting the requirements for quality standards and compliant documentation, capacity, product availability and cost. Collaboration and quality support for biocompatibility activities Collaboration and quality support for clinical trial activities Responsible for creating and maintaining technical documentation as part of the internal quality management system. Responsible for the project norms and standards process Approves the declaration according to MDR Annex XV Chapter II Section 4.1 for clinical investigational devices. Approves the issue of declarations of conformity. Submission of applications for clinical studies to authorities and ethics committees Your profile University degree or equivalent qualification in medicine, pharmacy, engineering, or other relevant scientific discipline plus min. 4 years of professional experience in regulatory affairs or quality management systems related to medical devices. Quality mindset, analytical and structured work, problem-solving ability, independence, communication skills, ability to work in a team Knowledge of pharmaceutical and/or medical device regulations Fluent in English and German, both spoken and written Fluent in PC office tools What we offer We offer a multifaceted job in an unusual, interesting, and socially relevant environment, with huge potential for personal and professional development. Diversity and inclusion are important to us. Place of work Moussonstrasse 13, Zürich, Switzerland Start of employment Immediately or upon agreement. Further information Sandro Matter, Project Leader Apply now If you apply for this position please say you saw it on Adminoxy

Wyss Zurich

Quality and Regulatory Affairs Manager
100 %

The Wyss Zurich Translational Center is a joint accelerator of the University of Zurich and ETH Zurich (Swiss Federal Institute of Technology Zurich), which was made possible by a generous donation from the Swiss entrepreneur and philanthropist Dr. h.c. mult. Hansjörg Wyss. It was established to foster translational research focused on developing treatment protocols and clinical therapies, as well as novel technologies and intelligent systems, in the emerging fields of Regenerative Medicine and Robotics, and hybrid technologies thereof. Wyss Zurich unites world-leading experts from both institutions in multidisciplinary teams, pooling their knowledge and expertise.

The Project LifeMatrix develops and manufactures tissue-engineered human matrices to repair and regenerate the heart.
A multidisciplinary team from Wyss Zurich Translational Center has developed a unique tissue engineering technology to grow replacement tissue in the laboratory, which will be compatible with every patient, regenerate and grow with the recipient. To create this tissue, cells of human origin are first grown in culture on a scaffold in the shape of a heart valve or blood vessel. In a process called decellularization, the cells are then removed, leaving behind a perfectly shaped, biologically neutral human tissue matrix called LifeMatrix. After implantation, the recipient's own cells will repopulate the LifeMatrix, replacing the biodegradable scaffold; and this tissue will continue to grow with the child. Such grafts will avoid repeated major surgery and its associated risks.
Previous work on autologous and personalized cellular tissues (patient receives tissue grown from his own body), which already obtained approval for a pilot clinical study by the German authority (PEI), is the basis for this next-generation tissue engineering technology. The Wyss Zurich Translational Center project aims to bring the LifeMatrix technology into the clinic with a first-in-human clinical trial.

Your responsibilities

Responsible for the compliance of all project activities with the internal quality management systems
Responsible for supplier quality management, including supplier audits.
Responsible for product development in the project and compliance with regulatory/legal requirements for product development.
Performs the required activities (e. g. create rationales, decision finding, protocols) and generates the appropriate documents to ensure compliance with national and international regulations related to medical devices (FDA, ISO 13485)
Plans and ensures the execution of all development activities, especially design verification and validation, including usability validation according to the internal quality management processes.
Ensures that the design history file (DHF) is created and maintained
Review of all the project DHF documents.
Responsible for the completeness and filing of the project DHF documents.
Release of the required project DHF documents.
Review and release of the relevant lot and batch records.
Coordinates the risk management activities with the process owner.
Coordinates all development activities in cooperation with the line manager and the process owners as appropriate.
Member of the Design Review Team
Collaboration in continuous improvement activities, including reporting deviations and suggestions for improvement
Collaboration and quality support for the relevant manufacturing activities, ensuring compliance with GMPs.
Supports the needs of manufacturing areas in terms of meeting the requirements for quality standards and compliant documentation, capacity, product availability and cost.
Collaboration and quality support for biocompatibility activities
Collaboration and quality support for clinical trial activities
Responsible for creating and maintaining technical documentation as part of the internal quality management system.
Responsible for the project norms and standards process
Approves the declaration according to MDR Annex XV Chapter II Section 4.1 for clinical investigational devices.
Approves the issue of declarations of conformity.
Submission of applications for clinical studies to authorities and ethics committees

Your profile

University degree or equivalent qualification in medicine, pharmacy, engineering, or other relevant scientific discipline plus min. 4 years of professional experience in regulatory affairs or quality management systems related to medical devices.
Quality mindset, analytical and structured work, problem-solving ability, independence, communication skills, ability to work in a team
Knowledge of pharmaceutical and/or medical device regulations
Fluent in English and German, both spoken and written
Fluent in PC office tools

What we offer

We offer a multifaceted job in an unusual, interesting, and socially relevant environment, with huge potential for personal and professional development.
Diversity and inclusion are important to us.