Quality and Regulatory Affairs Specialist

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.

The QA Specialist focusses on the development, implementation, and continuous improvement of the quality system in compliance with ISO 13485. She/He also works closely with the R&D and the production teams to ensure that the documentation meets all regulatory and medical requirements.


Responsibilities and Duties

Reporting to the Quality, Regulatory and Clinical Affairs Manager, your principal duties and responsibilities will be to:

  • Ensure that Quality System requirements are met in order to achieve and maintain compliance with applicable regulations.
  • Lead the preparation and execution of external and internal audits.
  • Lead the Management Review preparation and execution (KPIs review, trends analysis, ...)
  • Manage timelines for quality system planning.
  • Participate to CAPA and NCR investigations.
  • Lead Documentation Management (release, storage, archiving).
  • Ensure regulatory watch and inform colleagues on regulatory requirements and the impact of new and revised regulations on products and processes.
  • Participate in Technical Documentation development and maintenance.
  • Support compilation of relevant clinical submission
  • Support labeling implementation.
  • Other duties as assigned.

Challenges ahead:

  • ISO 13485 certification on going.
  • Electronic QMS system to assess then, potentially, to implement.

The expected profile

  • Bachelor’s or Master’s degree in life sciences, biomedical, mechanical, or microengineering, or a related field of study, or proven experience in the healthcare and life sciences industry.
  • Min. 2 years’ experience as a Quality Management System Specialist for medical devices. First experience in Regulatory Affairs an asset.
  • Consistent knowledge of Medical Device Industry standards and regulations (ISO 13485, ISO 14971, EU MDR 2017/745).
  • Rigor, methodical approach, detail-oriented, self-sufficient with the ability to work as part of a team that must be motivated to implement and comply with quality guidelines, a strong sense of responsibility.
  • High-quality writing in English and French. Sense of aesthetics for the elaboration of Word, Excel and PowerPoint documents.
  • Communication skills for oral presentations.
  • French or English mother tongue, other language level C1+ (German an advantage).
  • Ability and willingness to work in start-up environment.

Additional information

  • Strong development opportunities.
  • Starting date: May 2024.
  • Location: Lausanne (Epalinges).
  • Activity rate: 80-100 %.
  • Applicant must hold a valid Work Permit in Switzerland.
  • Recruitment agencies: please abstain.

If you are highly motivated by this position, please tell us how you envision your career in the coming years and how you could contribute to the success of Novostia in the current phase and for the next 3 years.
Your primary contact for this position is: p.boissier [at] novostia.com