Jr Regulatory Affairs Specialist

Nextkidney; Lausanne; Hybrid; CHF 85,000 - 110,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Analytical skills

Attention to detail

Organizational skills

Proactive problem-solving

Regulatory data synthesis

Education

Bachelor's degree in a scientific field

Tools

MS Word

MS Excel

Job description

Junior Regulatory Affairs Specialist (100%)

About the job

NextKidney SA is a fast-growing innovative company developing and commercializing the world’s first portable hemodialysis device. We do business in Europe, Asia, and US. You will collaborate with Investment funds (VC’s), foundations and companies all over the world and be part of an open modern working atmosphere where business and professional human values meet.

Our company mission : create a better life for Dialysis patients all over the world !

For our Regulatory Affairs Department

We are looking for a Junior Regulatory Affairs Specialist who supports the Regulatory Affairs department in ensuring compliance with regulatory frameworks governing product registration, submission, distribution, and post-market surveillance of medical devices across different jurisdictions, primarily EU and US.

Key responsibilities and accountabilities

Contribute to multidisciplinary teams and communicate regulatory requirements effectively.

Assist in preparing regulatory submissions for various regions.

Monitor and relay the impact of global regulatory changes.

Support the preparation of documents for : Audits, Interactions and correspondence to regulatory stakeholders (NCAs, NB, FDA).

Specific responsibilities

Regulatory Submissions

Prepare and compile necessary documentation for regulatory submissions in various jurisdictions.

Regulatory awareness and ability to proactively ensure compliance throughout document development.

Support the update of systematic literature or database reviews.

Support the report of safety events in accordance with regulatory requirements.

Quality Management Systems (QMS)

Contribute to maintaining regulatory processes within the QMS framework.

Participate in regulatory watch activities to identify and address changes in regulations.

Maintain the corresponding documentation Support continuous improvement by contributing ideas and proposing solutions where appropriate.

Knowledge, skills and abilities

Analytical skills

Rigorous attention to detail.

Strong organizational skill.

Ability to gather, organize, and synthesize regulatory data to support team decision-making.

Strong organizational skill.Proactive problem-solving skills and a continuous improvement mindset.

Technical skills

Strong skills in MS Word and Excel.

Excellent verbal and written communication skills in English and French.

Specific skills

Enthusiasm for continuous learning and staying updated with evolving regulatory requirements and technological advancements.

Understanding the interplay of regulatory documentation throughout the lifecycle of medical device development, marketing, and post-market maintenance.

Education and experience

Minimum of a 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.

Start of the mission

As soon as possible

Activity rate

100%

We offer

Participation to innovative projects being part of a team of experts

Access to latest technologies

A dynamic working environment where collaboration is one of the key elements

Administrative status

Valid Swiss work permit or EU/EFTA citizenship