sitem-insel AG

Available jobs

Junior Regulatory Affairs in Medtech (50% or more) (F/M)

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Decomplix simplifies market access for medical devices. As a legal manufacturer and Swiss Authorized Representative, Decomplix goes beyond consulting and assumes pre- and post-market responsibility. In times of more stringent regulatory hurdles, this business model provides Decomplix customers with legal protection, lower risks and shorter time-to-market. Quality management and regulatory affairs are our core competence. For the expansion of our core team, we are looking for a Junior Regulatory Affairs in Medtech (50% or more) (F/M)

 

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Software Compliance Manager Medical Devices (F/M), German & English (60% or more)

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Decomplix is a compliance partner that simplifies market access for medical devices. As a legal manufacturer, Decomplix goes beyond just consulting. Proven experts guide developers and manufacturers through the CE certification. In times of more stringent regulatory hurdles, this offering provides Decomplix customers with legal protection, lower risks, and shorter time-to-market. Quality management and regulatory affairs are our core competence. For the expansion of our small core team, we are looking for a Software Compliance Manager Medical Devices (F/M), German & English (60% or more).

 

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Confluence-Nerd (20 bis 100% oder Freelance)

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Decomplix vereinfacht Medizinprodukten den Marktzugang. Als Inverkehrbringer und Schweizer Be-vollmächtigter geht Decomplix über die Beratung hinaus und übernimmt Verantwortung vor und nach der Markteinführung. In Zeiten verschärfter regulatorischer Hürden ermöglicht dieses Angebot für Decomplix-Kunden rechtlichen Schutz, tiefere Risiken und verkürzte Time-to-Market. Qualitätsmanagement ist unsere Kernkompetenz. Zum Ausbau unseres Kernteams suchen wir einen Confluence-Nerd (20 bis 100% oder Freelance).

 

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CEO Ability Knowledge Software

Ability is a startup developing the next level software for personal education. With a new academic social medium we move beyond PDFs and websites, and introduce true interaction and information concentration - a quantum leap for building, sharing and updating quality knowledge.
We are currently building our team to found our startup company. We are in the phase of validating ideas, finishing the MVP and test, iterate and acquire first customers.
We are looking for a sharp, entrepreneurial, and driven mind that will act as CEO and lead a team of seven (five developers, project manager and CEO) to go from ideas to a successful product launch (…and beyond), and develop strategies for increasing user growth.

Scientific Collaborator - Medical Device Regulatory Affairs and Quality Assurance 60%

The sitem-insel School aims to promote researchers and train specialists in the fields of translational medicine and biomedical entrepreneurship.

 

The scientific collaborator contributes to the development and organization of courses and events organized by the sitem-insel School in collaboration with the program coordinators and module leaders. The position requires a regular interaction with outside scientific experts, but also with internal staff and participants of our School programs. 

 

The scientific collaborator will mainly be in charge of the scientific/technical coordination of the MAS/DAS Medical Device and Regulatory Affairs courses, organization of scientific events in RA and QA and is expected to work closely with module leaders on the development and update a.o. of the scientific content of the courses. The position is limited to 1 year and start immediately or upon mutual agreement.