Les résultats de la recherche: 29 offres d'emploi
Regen Lab SA based in Le Mont-sur-Lausanne. We are a Swiss leading medical device company comprised of a dynamic team dedicated to revolutionizing healthcare. Our commitment to innovation and excellence drives us to develop cutting-edge medical devices that positively ...
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...Job Description: As a Regulatory Affairs Manager you will be responsible for ensuring compliance with regulatory requirements related to... ...and submit regulatory submissions including Investigational New Drug (IND) New Drug Application (NDA) 510(k) PreMarket Approval (PMA...
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Temps plein
...Switzerland and the successful candidate is required to be in the Canton of Vaud. In this role, you lead the development and improvement of the regulatory affairs capabilities in Europe, Middle East and Africa. You provide strategic guidance regarding the impact of regula...
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...of registrations, renewals and lifecycle management;
Review and validate products’ artworks and marketing campaigns to ensure regulatory compliance;
Write and review SOP, WKI, FORM for regulatory affairs-related processes;
Manage non-conformity process in particular...
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...researchers from more than 120 different countries. Postdoc Position in Human Organoid-Based High-Throughput Systems for Anti-Infective Drug Discovery
Your mission :
We are excited to announce an open postdoc position on a groundbreaking project focused on the...
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Emploi postdoc
CDD
Durée déterminée
Swiss Federal Institute of Technology Lausanne, EPFL
Lausanne VD
il y a 4 jours
...For Use (IFU) for our medical devices, ensuring compliance with regulatory standards.
Register medical devices in various regulatory... ...the management of Instructions For Use for medical devices or drugs.
~ Familiarity with the structure of technical documentation...
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...oversight of commercial manufacturing activities associated with Drug substance, Drug Product and Britestock.
He/She assures... ...according to Incyte audit program,
Support the RA-CMC group for regulatory submissions and follow-ups,
Ensure inspection readiness at assigned...
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...dedicated to empowering researchers in immunology, immuno-oncology, and neuroscience to push the boundaries of scientific discovery and drug development. We build solutions that simplify technology adoption of spatial biology to support the development of diagnostic tools...
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Temps plein
CDI
Travail posté
...dedicated to empowering researchers in immunology, immuno-oncology, and neuroscience to push the boundaries of scientific discovery and drug development. We build solutions that simplify technology adoption of spatial biology to support the development of diagnostic tools...
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Temps plein
CDI
Travail posté
...dedicated to empowering researchers in immunology, immuno-oncology, and neuroscience to push the boundaries of scientific discovery and drug development. We build solutions that simplify technology adoption of spatial biology to support the development of diagnostic tools...
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Temps plein
...dedicated to empowering researchers in immunology, immuno-oncology, and neuroscience to push the boundaries of scientific discovery and drug development. We build solutions that simplify technology adoption of spatial biology to support the development of diagnostic tools...
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Temps plein
...biotechnologie, chimie ou un autre domaine
Excellente maîtrise des procédés pharmaceutiques, de préférence de la production de drug substance biotechnologique
Connaissance approfondie des activités de validation des procédés (analyse des risques, plan de validation...
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...dedicated to empowering researchers in immunology, immuno-oncology, and neuroscience to push the boundaries of scientific discovery and drug development. We build solutions that simplify technology adoption of spatial biology to support the development of diagnostic tools...
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Temps plein
...dedicated to empowering researchers in immunology, immuno-oncology, and neuroscience to push the boundaries of scientific discovery and drug development. We build solutions that simplify technology adoption of spatial biology to support the development of diagnostic tools...
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Remote job
...including related KPI is a key area to enhance existing processes.
~ Create configure and develop electronic manufacturing processes (Drug Substance Fill/Finishing Shared Services Plant Logistics)
Prepare specifications and related design documents
Oversee the...
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Temps plein
...biotech engineer pharmaceutical engineer process engineer chemist etc.)
Experience in the field of biotechnology production of Bulk Drug Substance
GMP experience
Good MSOffice knowledge
Ability to work in a fast paced high regulated environment
French and...
Temps plein
...with strict attention to detail.
~ Significant knowledge of medical device Quality Management Systems (ISO 13485, 21 CFR 820) and regulatory landscape (i.e. MDR).
~ Excellent communication skills and interpersonal relationship skills including negotiating and...
...100% Imm. CHF 110000
Tasks
Review negotiate and draft commercial contracts
Provide support on all legal matters incl. GDPR regulatory
Intepret existing agreements providing guidance on obligations potential disputes
Collaborate with crossfunctional teams to...
Temps plein
Temps partiel
...Qualification (PQ) for
computerized systems.
• Maintain comprehensive documentation for all CSV activities, ensuring adherence to regulatory standards and internal quality procedures.
• Collaborate with quality assurance teams to support regulatory inspections and...
Travail à domicile
Remote job
...Programs including Interface with external agencies as required including the FDA and the Notified Body.
Partner with Global Regulatory Affairs to assure integration of Regulatory Intelligence activities and changing expectations into the QMS
Support the development...
