Risultati della ricerca: 15 offerte di lavoro
...Ypsomade.
In the Business Area Diabetes Care in Solothurn we are looking for an experienced skilled personality as a
Regulatory Affairs Manager | 100%
Ref. No. 6448
Location:
Solothurn
| Hybrid
Help us bring to market state-of-the-art medical technology...
Consigliato
Tempo parziale
Lavoro a turni
Ypsomed AG
Soletta SO
un mese fa
...connected devices)
~Manage the development and implementation of regulatory strategies
~Support and prepare product submission documents... ...~At least 4 years of professional experience in Regulatory Affairs with focus medical device
~Expertise in Active Medical Devices...
Consigliato
...operational efficiency.
Documentation and Compliance: Coordinating and revising manufacturing documentation to ensure compliance with regulatory standards.
Team Development: Hiring, training, and developing a high-performing team, fostering a culture of collaboration and...
Consigliato
...Management: Initiate, own, and manage manufacturing-focused change controls, CAPAs, and planned exceptions, ensuring compliance with regulatory standards.
Problem Resolution: Provide solutions and training to resolve technical and operational problems, leveraging...
Consigliato
...Collaborate with them on joint projects in research and dissemination
~Work cross-functionally with sales, marketing, market access and regulatory teams to develop strategies and deliver specific programs
~Be the scientific and medical resource for the teams on the field
~...
Consigliato
...Zusammenarbeit mit sämtlichen involvierten Teams, insbesondere Produktentwicklung und unterstützenden Funktionen wie beispielsweise Regulatory Affairs
Ihr Profil
~Abgeschlossene Grundausbildung im Bereich Technik oder Naturwissenschaften
~Teilnahme an einer ISO 14971...
Consigliato
...Assembly / dismantling of equipment) according to instructions
Executing Daily site walkdown and recording in CMMS
Executing Regulatory PM tasks e.g. (boilers 72h checks, safety shower flush)
Addressing defined and straightforward identified issues according to...
Consigliato
Temporaneo
Apprendistato
Lavoro a turni
...understanding, support investigations & drive process improvements. You author and review technical documents, lead engagements during regulatory audits & filings and communicate project & technical issues.
What You'll Do
Key technical leader in USP process...
Consigliato
Tempo pieno
...facility for deviations, root cause analysis and CAPAs related to equipment and automation of the production process and applying regulatory and compliance knowledge from multiple markets/agencies.
Review and approve complex GMP documentation (Changes, plans,...
Consigliato
Tempo pieno
...Zusammenarbeit mit sämtlichen involvierten Teams, insbesondere Produktentwicklung und unterstützenden Funktionen wie beispielsweise Regulatory Affairs
Ihr Profil
Abgeschlossene Grundausbildung im Bereich Technik oder Naturwissenschaften
Teilnahme an einer ISO 14971...
Consigliato
...de vente inclut un large éventail de missions. Vous avez pour objectif de fournir une expérience client d'exception et d'accroître le chiffre d'affaires. Cet objectif implique de conseiller les clientes et clients de manière compétente en matière de VP, d'options de...
Consigliato
...facility for deviations, root cause analysis and CAPAs related to equipment and automation of the production process and applying regulatory and compliance knowledge from multiple markets/agencies.
Review and approve complex GMP documentation (Changes, plans,...
Consigliato
Tempo pieno
Biogen
Luterbach SO
un mese fa
...minimum of 5 years' hands-on involvement in developing embedded hardware solutions for medical devices, ensuring compliance with regulatory standards, and enhancing patient care and safety
~Demonstrated ability to lead cross-functional teams, fostering collaboration,...
Consigliato
...investigate QMS Deficiencies or reported quality issues to ensure resolution in accordance with company guidelines and external regulatory requirements
Maintain updated technical documentation (e.g. updating documentation)
Maintain a compliant and up-to-date Quality...
Consigliato
Tempo pieno
...experience in Developing Embedded Hardware Solutions, ideally including experience in Medical Devices, ensuring compliance with regulatory standards & enhancing patient care & safety.
Proven experience in Leading Cross-Functional Teams.
Any experience in Altium...
Consigliato
Tempo pieno
Home office
