Novostia is a clinical stage company founded in April 2017, in Switzerland, that is developing a breakthrough heart valve prosthesis offering superior benefits and quality of life to young adults and elderly people suffering from heart valve disease.Take up new challenges and join an innovative and dynamic team!
In support of the Quality, Regulatory and Clinical Affairs Manager, the primary duties and responsibilities of the Clinical Affairs

Expert are the following:

• Support clinical investigation conduct and ensure study project management.


• Maintain and update Trial Master File essential documents.


• Manage and coordinate study partners (CRO, CRA, Physicians) including contracts, tasks, timelines and budget follow-up.


• Ensure study results are regularly reported internally and support external communication preparation.


• Support clinical investigation initial submission and post-approval amendments to IRB/Ethics Committees and


• Competent Authorities (EU/USA).


• Support the communication with IRB/Ethics Committees and Competent Authorities (EU/USA).


• Support the setup of legal agreements/sponsorship with study stakeholders.


• Contribute to the development of the new clinical documentation (Protocol, Investigator Brochure, Case Report Form, clinical study reports, …).


• Contribute to the maintenance of Clinical Evaluation and creation of Post Market Clinical Follow Up Plan (PMCF) and


• Report, and Summaries of Safety and Clinical Performance (SSCPs).


• Develop and ensure continuous improvement of clinical procedures as part of the company Quality Management System.


• Provide inputs for the risk management file, designs reviews and technical documentation.


• Support RA excellence (support the establishment, maintenance and optimization of Regulatory Affairs processes and procedures including Device’s Technical Documentation as per MDR 2017/745).


• Support the company's clinical and regulatory strategic development plan.

The expected profile

• University Degree (PhD / MSc) in Life Sciences, Pharmaceutical, Medical devices, or similar relevant discipline.


• At least 5 years of experience in the medical device field (cardiovascular and/or Class III preferred) in


• Clinical Affairs senior function. Additional experience in Regulatory Affairs is preferred.


• Solid understanding and consistent background in medical device industry regulations in Europe (MDR
  2017/745) and the USA (FDA 21 CFR 820 & 21 CFR 11).


• Thorough knowledge of international standards relevant to the role, including ISO 13485, ISO 14155,
  and ISO 14971.


• Practical experience with clinical investigation management in EU and/or the USA.


• Experience working with competent authorities in Europe and/or the USA.


• Team player who can inspire credibility and confidence within and outside the company.


• Exemplary human values and business ethics.


• Ability and willingness to work in start-up environment.


• At least, C1 equivalent level in English. Proficiency in French is a strong advantage.

Additional information

• Starting date: as soon as possible


• Location: Lausanne


• Activity rate: 80-100%


• Attractive work conditions


• Applicants must hold or be eligible for a work permit in Switzerland


• Recruitment agencies: please abstain

If you are highly motivated by the position and believe you meet at least 80% of the qualifications, please explain your career plan and tell us how you can contribute to Novostia in the current phase and for the next 3 years. Your primary contact for this position is: p.boissier@novostia.com