...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...
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Teilzeitarbeit
Schichtarbeit
Ypsomed AG
Solothurn SO
Vor 20 Tagen
...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...
Empfohlen
...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...
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Vollzeit
...improvements. Author and review technical protocols & reports for process validation, investigations, process sciences studies and regulatory commitments.
What You'll Do
Coordinate cross-functional process transfer sub-teams (Operations, Development, Process and...
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Vollzeit
...computerized systems Qualification and Cleaning/Sterilization Validation are successfully executed according to current GMP and regulatory policies.
Review and approval of Validation, Engineering and Manufacturing documents during both project and operational phases...
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Biogen International GmbH
Luterbach SO
Vor 27 Tagen
...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,...
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Vollzeit
Biogen
Luterbach SO
Vor 21 Tagen
...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...
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...Risikomanagement
Bearbeitung und Umsetzung von Produktänderungen und CAPAs
Enge Zusammenarbeit mit Produktmanagement, Medical Affairs, Produktion und Regulatory Affairs für den Produktunterhalt
Unterstützung von Länderregistrierungen
Planung, Betreuung und Durchführung...
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Selbständige Tätigkeit
Festanstellung
...factors, production and other involved departments
~Close collaboration with verification teams
~Ensure coverage of standards and regulatory requirements
~Maintain the requirements, traceability and architecture in the requirements management tool over the product...
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...Sound knowledge of cGMP requirements, EU/FDA regulations and compliance.
Experience in clinical products manufacturing and/or regulatory is an asset. Knowledge of medical device regulations and manufacturing is a plus.
Ability to develop effective working...
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...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...
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...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...
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Vollzeit
...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...
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...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...
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...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,...
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...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...
Vollzeit
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