International company|Medical devices About Our Client: Our client is an international company specialized in medical devices. Job Description:
Technical documentation writing management (for Europe & the US);
Involvement in the development and design of the company...
Suggéré
...analytical methods remain compliant with MAAs / BLAs and with evolving regulatory requirements.
Ensure cross-product deployment of strategy.... ...Demonstrated success operating in a global matrix organization with the full breadth of functions contributing to drug development
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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, instruments and/or facilities are compliant with regulatory standards.
Utilities: commissioning and qualification of utilities (ex. purified water systems, clean steam systems, HVAC...]]...
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...and ensure compliance with project requirements.
• Work closely with cross-functional teams, including engineering, operations, regulatory affairs, and quality assurance, to ensure alignment with project goals
• Communicate project progress and challenges to...
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Travail à domicile
Remote job
...description
Develop and execute validation protocols to ensure processes, instruments and/or facilities are compliant with regulatory standards.
Utilities: commissioning and qualification of utilities (ex. purified water systems, clean steam systems, HVAC...
Suggéré
Travail à domicile
Remote job
...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...
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...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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Building the bank of tomorrow takes more than skills.
It means combining our differences to imagine, discuss, code, develop, test, learnÂ
and celebrate every step together. Share our vibes? Join Swissquote to unleash your potential.
We are the Swiss Leader in Online...
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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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Building the bank of tomorrow takes more than skills.
It means combining our differences to imagine, discuss, code, develop, test, learn… and celebrate every step together. Share our vibes? Join Swissquote to unleash your potential.
We are the Swiss Leader in Online...
Suggéré
Temps plein
...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
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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Entreprise :
Notre client est une entreprise internationale spécialisée dans le développement de dispositifs médicaux.
Description du poste :
* Collaborer à la réalisation du design avec les départements Marketing, Affaires Réglementaires et R&D
* Etablir les spécifications...
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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...
Suggéré
...oversight of commercial manufacturing activities associated with Drug substance, Drug Product and primary packaged Product.
He... ...Cooperate with the Supply Chain, Commercial Operations and Regulatory Affairs functions.
Requirements
Student in Bachelor...
Temps plein
...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...
Temps plein
...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...
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...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...
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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...
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...
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...
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...
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...
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...
Temps plein
...compliance and cross-border
Providing support to the front line and ensuring the resolution of compliance issues
Managing key regulatory projects in the field of AML
Updating policies and procedures following regulatory and systems changes
Training and...
...compliance with ISO 13485. She/He also works closely with the R&D and the production teams to ensure that the documentation meets all regulatory and medical requirements.
Responsibilities and Duties
Reporting to the Quality, Regulatory and Clinical Affairs Manager...
Recrutement immédiat
...on the development, implementation, and continuous improvement of the quality system in compliance with ISO 13485. She/He also works closely with the R&D and the production teams to ensure that the documentation meets all regulatory and medical requirements. Respons...
...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...
Temporaire
...areas of accounting and financial controlling
Reporting: Contribute to the automation of internal and external processes and regulatory reporting
Financial Analysis: Conduct data-driven financial analysis to support decision-making
Ad-hoc Projects: Participate...
Temps plein