Clinical and Regulatory Affairs Expert

Novostia is a start-up company developing a unique heart valve prosthesis with the mission to improve the quality of life for patients suffering from heart valve disease, especially children and young patients.

Take up new challenges and join our innovative and dynamic team for an exciting internship!

In support of the Quality, Regulatory and Clinical Affairs Manager, your primary duties, and responsibilities as a Clinical and Regulatory Affairs Expert will consist in the following:

  • Support the clinical investigation submissions 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 the hospitals.

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

  • Contribute to the development of Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Post Market Clinical Follow up Plan (PMCF), PMCF Report, and Summaries of Safety and Clinical Performance (SSCPs).

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

  • Ensure RA excellence (support the establishment, maintenance and optimization of Regulatory Affairs processes and procedures).

The expected profile:

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

  • At least 7 years of experience in the medical device field (cardiovascular and/or Class III preferred) as Clinical Affairs Manager and/or Regulatory Affairs Manager or comparable function.

  • Consistent background and knowledge in Medical Device industry regulations in Europe and the USA (ISO 13485:2016 & 2017/745 MDR; FDA 21 CFR 820 & FDA 21 CFR 11).

  • Practical experience with clinical investigation submission in EU and/or the US.

  • Experience working with Swissmedic and/or other competent authorities in Europe.

  • 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.

  • Excellent written and verbal English communication skills (French is a plus).

Additional information:

  • Starting date: April ideally.

  • Location: Lausanne

  • Activity rate: 80-100%

  • Attractive conditions

  • Applicant must be holder of/or eligible for a work permit in Switzerland.

In case of interest, please send your application to: p.boissier [at]