Junior Regulatory Affairs Specialist - Medical Devices

Nextkidney; Lausanne; Híbrido; CHF 85.000 - 110.000; Jornada completa

Descripción de la vacante

NextKidney is seeking a Junior Regulatory Affairs Specialist to support regulatory submissions, maintain QMS processes, and monitor global regulatory changes across EU and US regions. The role requires a scientific degree and 2 years in medical device regulations, with strong English and French communication.

Join a fast-growing company delivering innovative portable hemodialysis solutions and collaborate across multidisciplinary teams in a dynamic environment with Swiss work permit validity.

Formación

• Bachelor's degree in a scientific field such as Science, Pharmacy, or Engineering.
• 2 years of experience working with medical devices and their associated regulations.

Responsabilidades

• Prepare and compile regulatory submissions for various regions.
• Contribute to regulatory submissions and document development across jurisdictions.
• Monitor and relay the impact of global regulatory changes.
• Support audits, interactions and correspondence to regulatory stakeholders (NCAs, NB, FDA).
• Maintain regulatory processes within the QMS framework.
• Participate in regulatory watch activities and identify changes in regulations.

Conocimientos

Analytical skills

Attention to detail

Organizational skills

Proactive problem-solving

Regulatory data synthesis

Educación

Bachelor's degree in a scientific field

Herramientas

MS Word

MS Excel

Descripción del empleo

NextKidney is seeking a Junior Regulatory Affairs Specialist to support regulatory submissions, maintain QMS processes, and monitor global regulatory changes across EU and US regions. The role requires a scientific degree and 2 years in medical device regulations, with strong English and French communication.

Join a fast-growing company delivering innovative portable hemodialysis solutions and collaborate across multidisciplinary teams in a dynamic environment with Swiss work permit validity.