...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
Suggéré
...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...
Suggéré
...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...
Suggéré
Heures supplémentaires
Tandem Diabetes Care Switzerland Sàrl
Canton de Vaud
il y a 17 jours
...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...
Suggéré
Tandem Diabetes Care Switzerland Sàrl
Canton de Vaud
il y a 17 jours
...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…...
Suggéré
Sous-traitant
Temporaire
Tandem Diabetes Care Switzerland Sàrl
Canton de Vaud
il y a 16 jours
...are growing their skills portfolio and boosting their career in a fast-pace environment
Are you all in? Dont be shy, apply!
Regulatory reporting officer (Temporary- 6 months)
Perform daily transactional reporting tasks to domestic and foreign regulators and...
Suggéré
Temporaire
Swissquote
Gland VD
il y a 2 jours
...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...
Suggéré
jobup
Lausanne VD
il y a 9 jours
...to 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...
Suggéré
RegenLab SA
Le Mont-sur-Lausanne VD
il y a 16 jours
...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
...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
...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...
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...
Suggéré
...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...
Suggéré
Durée déterminée
...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:...
Suggéré
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 ...
Suggéré
...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...
...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...
Temps plein
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...
...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...
...en 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...
Agap2 - HIQ Consulting AG
Lausanne VD
il y a 3 jours
...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
...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...
Temps plein
...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 team when...
Temporaire
Coface RE
Lausanne VD
il y a 10 jours
...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...
Electro Medical Systems S.A.
Nyon VD
il y a 22 jours
...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...
Swissquote
Gland VD
il y a 3 jours
...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
...work effectively in a cross-functional team and adapt to evolving priorities.
Quality-driven mindset with a keen attention to detail.
Regulatory knowledge and experience with health authority inspections is a plus.
Based in St-Prex (Vaud)
Duration 6 months
Manpower
Saint-Prex VD
il y a 16 jours
...and design, deploy, support data leakage security controls.
Always bring solutions in adequation with business objectives, regulatory constraints and ensure the protection of user and customer identities by managing the IAM team for design and support of IAM/PAM...
Noël
Remote job
Audemars Piguet
Le Brassus, Le Chenit, VD
il y a 3 jours
...used in competition in all the cycling disciplines.
Regular checks of the compliance of equipment used in competition with the regulatory requirements.
Management of special unannounced equipment checks during competition to ensure compliance with UCI regulations....
Recrutement immédiat
Union Cycliste Internationale
Aigle VD
il y a 4 jours
...Attractive additional benefits
Position Summary
As the Head of Medical Education and Affairs within our Global Medical, Regulatory, and Scientific Unit team, you will play a pivotal role in driving science-based nutrition information and education initiatives...
Temps plein
Nestlé Operational Services Worldwide SA
Vevey VD
il y a 24 jours