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
#J-18808-Ljbffr
Jr Regulatory Affairs Specialist in Lausanne Arbeitgeber: Nextkidney
NextKidney SA ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern die Möglichkeit bietet, an innovativen Projekten im Bereich der tragbaren Hämodialysegeräte zu arbeiten. Mit einem dynamischen Arbeitsumfeld, das Zusammenarbeit und persönliche Werte fördert, sowie Zugang zu modernster Technologie, unterstützt das Unternehmen die berufliche Weiterentwicklung seiner Mitarbeiter und bietet eine sinnvolle Tätigkeit zur Verbesserung des Lebens von Dialysepatienten weltweit.
