Junior Regulatory Affairs Specialist

• 30 septembre 2026
• 100%
• Indefinite duration
• Avenue de Sévelin 28, 1004 Lausanne
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NextKidney SA is an innovative, fast-growing company developing and marketing the world's first portable hemodialysis device. We operate in Europe, Asia, and the United States. You will collaborate with investment funds (VC), foundations, and companies worldwide and will be part of a modern and open working atmosphere where professional and human values meet.

Our corporate mission: creating a better life for dialysis patients worldwide!

Junior Regulatory Affairs Specialist

The Junior Regulatory Affairs Specialist supports the Regulatory Affairs department to ensure compliance with the regulatory frameworks governing product registration, submissions, distribution, and post-market surveillance of medical devices in different jurisdictions, primarily the EU and the United States.

Key responsibilities and missions

• Contribute to multidisciplinary teams and effectively communicate regulatory requirements.
• Assist in the preparation of regulatory files for various regions.
• Monitor and convey the impact of global regulatory changes.
• Support the preparation of documents for: audits, interactions, and correspondence with regulatory stakeholders (ANC, NB, FDA).
• Evaluate labeling and marketing materials to ensure their compliance.

Specific responsibilities

Regulatory files

• Prepare and compile the documentation necessary for regulatory files in various jurisdictions.
• Regulatory knowledge and ability to proactively ensure compliance throughout the development of documents.

Post-market surveillance

• Support the updating of systematic literature reviews or databases.
• Support the reporting of safety events in accordance with regulatory requirements.

Quality Management Systems (QMS)

• Contribute to the maintenance of regulatory processes within the QMS framework.
• Participate in regulatory intelligence activities to identify and address regulatory developments.
• Support continuous improvement by bringing ideas and proposing solutions when appropriate.

Knowledge, skills and abilities

Analytical skills

• Rigor and attention to detail.
• Excellent organizational skills.
• Ability to collect, organize, and synthesize regulatory data to support team decision-making.
• Proactive problem-solving skills and a continuous improvement mindset.

Technical skills

• Advanced proficiency in MS Word and Excel.
• Excellent oral and written communication skills in English and French.

Specific skills

• Enthusiasm for continuous learning and staying up to date with regulatory requirements and technological advancements.
• Understanding of the interaction of regulatory documentation throughout the lifecycle of development, commercialization, and post-market maintenance of medical devices.

Education and experience

• Minimum bachelor's degree in a scientific field such as science, pharmacy, or engineering.
• 2 years of experience in the field of medical devices and their associated regulations.

Administrative status

• Valid Swiss work permit or EU/EFTA citizenship

Please apply directly to this position via Jopup.