...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 regulatory issues...
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Entreprise internationale|Dispositifs médicaux About Our Client: Notre client est une entreprise internationale spécialisée dans le développement de dispositifs médicaux. Job Description:
Collaborer à la réalisation du design avec les départements Marketing, Affaires...
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...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 and...
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...Job description
Develop and execute validation protocols to ensure processes and instruments are compliant with regulatory standards.
Oversee the commissioning and qualification of utilities (ex. purified water systems, clean steam systems, HVAC systems, and...]...
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...team for this area ( 2 people for 2025)
· Provide conformity and application of the QMS for the project.
· Ensure audits and regulatory inspections in the context of the project.
· Collaborate actively with the business partners.
· Provide leadership to build up...
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Festanstellung
...device data management, creation and maintenance of associated documentation ;
Support in QMS improvements and audits ;
Ensure regulatory compliance and process optimization ;
Cross-functional collaboration and advice to internal teams. The Successful Applicant:...
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...and shipping samples, coordinating the teams.
Compile and manage test results and write reports that will be used to support regulatory submissions for our products.
Write detailed and easily understood work instructions, test protocols, and test reports.
Review...
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Tandem Diabetes Care Switzerland Sàrl
Kanton Waadt
Vor 9 Tagen
...integral to validating the functionality, efficiency, and reliability of the Sigi™ system in preparation for clinical trials and regulatory submissions.
Working from Tandem Diabetes Care Switzerland’s office onsite in Switzerland, you’ll….
Meticulously execute test...
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Überstunden
Tandem Diabetes Care Switzerland Sàrl
Kanton Waadt
Vor 9 Tagen
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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...the direction and leads the Mechanical & Electrical Engineering teams responsible for developing an exceptional product through regulatory approval, and transfer to manufacturing.
Working from Tandem Diabetes Care Switzerland’s office onsite in Switzerland, you’ll…...
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Subunternehmer
Temporär
Tandem Diabetes Care Switzerland Sàrl
Kanton Waadt
Vor 8 Tagen
...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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Vollzeit
LHH Recruitment Solutions is a specialized talent recruitment boutique. We provide tailored services to help companies find the best candidates for their staffing needs. With deep industry expertise and a commitment to excellence, LHH RS is a trusted partner in Switzerland...
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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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Postdoc Stelle
CDD
Festanstellung
Swiss Federal Institute of Technology Lausanne, EPFL
Lausanne VD
Vor 2 Tagen
...for a dynamic professional to step into a pivotal role that includes responsibility in Design Control Quality Assurance (QA) and Regulatory Affairs (RA) for one of our clients.
KEY RESPONSIBILITIES
Oversee Project Excellence Quality Assurance and Design Control:...
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Vollzeit
...innovation and excellence drives us to develop cutting-edge medical devices that positively impact patients' lives worldwide.
Regulatory Affairs Manager
Position Overview:
For our site located in Le Mont-sur-Lausanne, we are seeking a highly skilled and motivated...
RegenLab SA
Le Mont-sur-Lausanne VD
Vor 8 Tagen
...recognized products. The new position of a Manager for Sterile Drug Product requires significant experience in manufacturing... ...(FMEA)
~ Understanding of process engineering analytical and regulatory aspects of sterile drug product manufacturing
Your solutionoriented...
Vollzeit
...packaging and testing activities associated with Small Molecules Drug substances, Drug Products and Primary Packaged Products.
The... ...partners and Incyte,
Support Incyte and license partners regulatory submissions as well as product launches,
Cooperate with the...
...at a newly ramped up Manufacturing Site for Oral Solid Dosage Drugs and a Center of Excellence for projects and New Product Introductions... .../reports.
Conduct and assist others in industry and regulatory research including research into industry standards/FDA guidelines...
Vollzeit
...industry
~ Thorough understanding of cGMPs and Swiss EU and FDA regulatory requirements
Your tasks: * This position is responsible... ...validation
Experience in Data Integrity
Good understanding of the drug development process from discovery through to regulatory filing...
Vollzeit
...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...
Vollzeit
CDI
Schichtarbeit
...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...
Vollzeit
CDI
Schichtarbeit
...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...
Vollzeit
...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...
Vollzeit
...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...
Vollzeit
...functional teams, provide legal guidance, and contribute to the success of our medical devices business.
TASK & RESPONSIBILITIES
Regulatory Compliance:
Interpret and apply relevant Swiss and international regulations related to medical devices.
Advise on quality...
Overview:
The QC Specialist is responsible for the QC Physico-Chemistry operational activities related to Drug Substance (DS), In-Process-Control (IPC) and Raw Materials (RM) testing & release at Incyte QC Bioplant.
This includes (but is not limited to) the planification...
...monitoring.
~ Assisting with document preparation for internal/external auditors; Addressing auditors’ requests; Contributing to regulatory and compliance projects.
~ Supporting various finance and accounting related projects.
~ Assisting the Finance...
Temporär
...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...
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...
Vollzeit