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.
Post-Market Surveillance
- 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 documentationSupport 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
To apply
Please apply for this position directly through Jobup.
Administrative status
Valid Swiss work permit or EU/EFTA citizenship