The Liver4Life project - a Wyss Zurich project- started in 2015. Our mission is the regeneration & treatment of human organs (livers) outside the body through advanced, smart and physiological perfusion systems.

Liver4Life developed a medical perfusion device (PD) intended for the machine perfusion of human donor livers. During this time, medical professionals can preserve it and its function can be assessed ex-situ prior to transplantation. The perfusion device is indicated for human liver allografts harvested for transplantation use, in particular extended criteria for human liver allografts.

Our multi-national, interdisciplinary team is looking for an experienced (Senior) Regulatory Affairs Manager that will help us obtain market approval for the US and other markets, advice the development team in regulatory aspects, play an active role in the small but agile team and create a solid regulatory backbone to build life-saving and -changing devices.

• Develop and manage regulatory strategies and provide clear guidance and information to internal and external stakeholders.
• Act as the regulatory liaison and primary contact person for FDA, support or lead negotiations on regulatory issues and organize meetings and teleconferences, if required.
• Lead and manage regulatory submissions (510k, De Novo, PMA) during development and life cycle management to FDA.
• Manage submission processes and ensure regulatory compliance.
• Advise on national submission matters and any specific additional national requirements, and identify deficiencies requiring resolution.
• Management of regulatory documents for submission. This includes any national documents required for submission, labelling, and artwork implementation.
• Keep up to date with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives with a particular focus on FDA regulations.
• Where applicable, mentor/instruct and guide internal and external reports including consultants and service providers. Plan, assign and direct work; manage competing priorities as appropriate.
• Lead or support projects to enhance the functionality and improve processes of the organization and/or to adapt to a regulatory environment.
• Contribute to product strategy and actively participate in further development of perfusion machine and its components.
• Participation throughout the entire design control process, including software, hardware, sterility, biocompatibility, and electronic safety facets.
• Staying abreast with innovations and research in related fields.
• Building and maintaining a network throughout the industry.

• Degree in natural sciences, engineering or medicine and additional professional training in quality and regulatory matters.
• >5 years of experience in an interdisciplinary, regulated environment; ideally medical devices with >3 years of proven experience in regulatory affairs with an emphasis on regulatory submissions and authorizations in the US or at a regulatory authority.
• Deep knowledge of US laws, regulations, guidelines and other requirements for medical device marketing authorization and maintenance.
• Working experience with FDA.
• Be detailed-oriented, well-organized, flexible and self-motivated.
• Very high ethical standards.
• Ability to interact and communicate effectively with regulatory authorities and stakeholders in a multinational environment.
• Experience in medical device development, including familiarity with key standards/legislations, e.g. 21CRF820, ISO 13485, ISO 60601, ISO 14971.
• Interest and willingness to proactively work towards the group’s goals.
• Familiarity with the Swiss Startup environment.
• Strong interest in interdisciplinary work and willingness to dive into new topics and understand medical requirements.
• Excellent interpersonal skills. Ability to effectively communicate and work across functions in a multinational organization to accomplish results.
• Fluency in English.

ETH Zurich is a family-friendly employer with excellent working conditions. You can look forward to an exciting working environment, cultural diversity, and attractive offers and benefits.

We look forward to receiving your online application with the following documents:

• Motivation Letter
• CV
• Diplomas and Work Certificates

Please note that we exclusively accept applications submitted through our online application portal. Applications via email or postal services will not be considered.

Questions regarding the position should be directed to Mr Waldemar Hoffmann, email waldemar.hoffmann@wysszurich.ch (no applications).

For recruitment services, the GTC of ETH Zurich apply.