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 !
Position description
Supporting the Regulatory Affairs department in ensuring compliance with regulatory frameworks governing product registration, submission, distribution, and post-market surveillance of medical devices across different market 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 D&D traceability activities through the successive development stages and monitor that the necessary verification and validation processes are carried out and documented.
- Support the preparation of documents for : Audits, Clinical studies, Replies to regulatory stakeholders (NCAs NB, FDA).
- Evaluate labeling and marketing materials for compliance.
Specific responsibilities
Regulatory Submissions
- Prepare and compile necessary documentation for regulatory submissions in various jurisdictions.
- Ensure compliance with relevant regulatory standards and guidelines
- Maintain communication with regulatory authorities to facilitate submissions and approvals.
Post-Market Surveillance
- Update of systematic literature or database reviews.
- Monitor and report safety events in accordance with regulatory requirements.
Quality Management Systems (QMS)
- Maintain and update regulatory processes within the QMS framework.
- Participate in regulatory watch activities to identify and address changes in regulations.
- Engage in risk management activities and ensure compliance with applicable standards.
- Actively contribute to the improvement of the organization by proposing and implementing innovative solutions.
Knowledge, skills and abilities
Analytical skills
- Rigorous attention to detail.
- Strong organizational skill.
- Ability to mobilize multidisciplinary knowledge and provide structured solutions to regulatory questions.
- Ability to identify relevant sources of information to answer regulatory questions.
- 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.
- Demonstrated initiative in identifying and implementing process improvements.
Education and experience
- Minimum of a Bachelor's Degree in a scientific field such as Science, Pharmacy, or Engineering.
- 2-4 years of experience working with medical devices and their associated regulations.
Administrative status
Possession of Swiss working permit
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