Regulatory Project Manager

vor 3 Wochen

Rotkreuz, Schweiz Work Selection Vollzeit

**Beschreibung**: For our international medical partner, Roche Diagnostics Int Ltd based in Rotkreuz, we are looking for a qualified and motivated
**Regulatory Project Manager** for one year with option for extension.
**Tasks**:

- Manages regulatory responsibilities associated with the development, support, and deployment of the Company’s non-medical and medical device software products
- Manages development and implementation of regulatory strategies and plans to support the timely introduction of new products and the possible preparation and review of government submissions to achieve timely and cost effective clearance/approval. Provides information for maintaining registrations and listings
- Monitors and assesses domestic and international Regulatory developments (e.g. Federal Register publication/notices, FDA and EU guidelines, etc.) related to the Company’s products
- Reviews product labeling to ensure conformance with applicable regulatory requirements and/or approved product claims Review promotional materials. May serve as a contact with affiliates to achieve international registration of products
- Frequent contact with external resources and contacts at various management levels concerning operations or scheduling of specific phases of projects
- Provide Expertise in Software as a Medical Device (SaMD), MDR, and IVDR and related regulations and guidance documents in U.S., Europe, Canada, and APAC. For example, 21 st Century Cures Act and related FDA guidance documents, Medical Device Regulation (MDR), EU guidance documents, IEC 62304, ISO 13485, ISO 14971, AAMI TIR45, AGILE development, etc.

**Must Haves**:

- Minimum degree bachelor or masters in engineering or biomedical engineering
- At least 5 years of experience in regulatory affairs working within medical device
- Experience with software, SaMD; working knowledge of software and software development
- Strong understanding of US regulations and FDA
- Profound knowledge of EU guidance documents
- Experience with MDR
- Experience with submissions for US and EU
- Engagement and communication with global health authorities
- Hands-on experience in stakeholder management

  • Regulatory Project Manager

    vor 1 Monat

    Rotkreuz, Schweiz Work Selection Vollzeit

    **Beschreibung**: For our international medical partner, Roche Diagnostics Int Ltd based in Rotkreuz, we are looking for a qualified and motivated Senior Systems Engineer for one year with option for extension. **Tasks**: - Manages regulatory responsibilities associated with the development, support, and deployment of the Company’s non-medical and medical...

  • Regulatory Affairs Manager

    vor 23 Stunden

    Rotkreuz, Schweiz Global Kader Personal Vollzeit

    **INTRODUCTION**: As a preferred supplier for Roche Diagnostics Int Ltd in Rotkreuz, we are looking for an individual as **Regulatory Affairs Manager**: - (contract for 2 years with possible extension). The earliest start date is within 2 months. Home Office: hybrid possible. **ASSIGNMENT DESCRIPTION**: - Provides support to currently marketed products,...

  • Regulatory Affairs Manager

    vor 23 Stunden

    Rotkreuz, Schweiz Manpower Suisse Vollzeit

    For one of our clients, a leading global pharma company in Rotkreuz near Zürich, we are currently looking for a **Regulatory Affairs Manager.** **Background**: **General Information**: - Start date: 1.2.23 - latest Start Date: 1.3.23 - End date: 2 years but may need to extend - Extension: Possible - Workload: 70-100% - Home Office: hybrid - Flexible...

  • Regulatory Affairs Manager/ivd

    vor 4 Wochen

    Rotkreuz, Schweiz Coopers Group AG Vollzeit

    **Regulatory Affairs Manager/IVD** In this role you will manage activities associated with regulatory approval of** in vitro diagnostic medical device**s. You will be responsible for activities which lead to and maintain domestic and international regulatory approval to market devices. Additionally, you are responsible for assessment of device changes for...

  • Regulatory Affairs

    Vor 2 Tagen

    Rotkreuz, Zug, Schweiz F. Hoffmann-La Roche AG Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Regulatory Affairs Manager 70-100%

    vor 4 Wochen

    Rotkreuz, Schweiz Work Selection Vollzeit

    **Beschreibung**: For our international medical partner, Roche Diagnostics Int Ltd based in Rotkreuz, we are looking for a qualified and motivated **Regulatory Affairs Manager** for one year with option for extension. **Tasks**: - Provides support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product...

  • Regulatory Affairs Manager

    vor 1 Monat

    Rotkreuz, Schweiz Coopers Group AG Vollzeit

    **Regulatory Affairs Manager** You will support various software as medical device and non-medical device software at different stages of the product lifecycle. This role is responsible for activities associated with regulatory approval or launch of regulated (medical device) and non-regulated software including the overall development, implementation and...

  • Regulatory Affairs

    vor 1 Tag

    Rotkreuz, Zug, Schweiz F. Hoffmann-La Roche AG Vollzeit

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...

  • Project Manager

    vor 1 Monat

    Rotkreuz, Schweiz IQVIA Vollzeit

    **Workload: 50-80% - Temporary contract** IQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. IQVIA creates intelligent connections across all aspects of healthcare through its analytics, transformative technology, big data resources and extensive domain expertise....

  • Senior Project Manager

    Vor 2 Tagen

    Risch-Rotkreuz, Schweiz FLEXSIS Vollzeit

    EINFÜHRUNG: Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competencies within the Interiman Group, we offer customized solutions in personnel consulting.With 25 years of experience and expertise, we offer companies unique and individual solutions in personnel...

  • Project Manager Ecommerce

    vor 4 Wochen

    Rotkreuz, Schweiz Global Personal Partner Vollzeit

    **EINFÜHRUNG**: Unser Beruf und unsere Leidenschaft «HR-Management». Global Personal ist ein eigenständiges Unternehmen der Interiman Group SA mit über 100 Mitarbeitenden, die an 21 Standorten in der Deutschschweiz ein komplettes Programm von Dienstleistungen im Bereich Human Resources anbieten. Für unseren Mandanten, ein Unternehmen Rotkreuz suchen...

  • Senior Project Manager

    Vor 2 Tagen

    6343 / Risch-Rotkreuz, Schweiz Flexsis AG, Filiale Basel LS Vollzeit

    EINFÜHRUNGFlexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competencies within the Interiman Group, we offer customized solutions in personnel consulting.With 25 years of experience and expertise, we offer companies unique and individual solutions in personnel...

  • Global Project Manager

    vor 1 Monat

    Rotkreuz, Schweiz Work Selection Vollzeit

    **Beschreibung**: Für unseren langjährigen und bekannten Geschäftspartner, Roche Diagnostics Schweiz AG mit Sitz in Rotkreuz, suchen wir einen motivierten und engagierten **Global Project Manager** für einen temporären Einsatz von einem Jahr mit Option auf Verlängerung. **Tätigkeiten**: - Unterstützt die Einrichtung und Implementierung von...

  • Change Control Manager 70-100%

    vor 1 Monat

    Rotkreuz, Schweiz Work Selection Vollzeit

    **Beschreibung**: For our long-standing and well-known business partner, Roche Diagnostics Schweiz AG, based in Rotkreuz, we are looking for a motivated and committed **Change Control Manager** for a temporary assignment of 12 months with the option to extention. **Tasks**: - Managing change execution and change Coordination in the area of Global...

  • QA Manager

    vor 1 Monat

    Rotkreuz, Schweiz Novartis Argentina Vollzeit

    Job ID- 363611BR- Feb 14, 2023- Switzerland**Job Description**: - 2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, its growth, innovation, culture...

  • Project Manager Ecommerce

    vor 4 Wochen

    Rotkreuz, Schweiz Work Selection Vollzeit

    **Beschreibung**: Wir suchen für unseren Kunden, Roche Diagnostics Schweiz AG mit Sitz in Rotkreuz, einen motivierten und engagierten **Project Manager eCommerce & Process Excellence **für einen temporären Einsatz von einem Jahr mit Option auf Verlängerung. Sie werden für die Abteilungen Order Management / Commercial Operations der Schweizer...

  • Project Manager Ecommerce

    vor 4 Wochen

    Rotkreuz, Schweiz Work Selection Vollzeit

    **Beschreibung**: Wir suchen für unseren Kunden, Roche Diagnostics Schweiz AG mit Sitz in Rotkreuz, einen motivierten und engagierten **Project Manager eCommerce & Process Excellence **für einen temporären Einsatz von einem Jahr mit Option auf Verlängerung. Sie werden für die Abteilungen Order Management / Commercial Operations der Schweizer...

  • QA Manager Medical Devices

    vor 1 Monat

    Rotkreuz, Schweiz Novartis Argentina Vollzeit

    Job ID- 363665BR- Feb 15, 2023- Switzerland**Job Description**: - 2023 will see Sandoz become a standalone organization! As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength! Those joining Sandoz in the coming months will help shape the future of the company, its growth, innovation, culture...

  • Design Ops Manager

    vor 23 Stunden

    Rotkreuz, Schweiz Work Selection Vollzeit

    **Beschreibung**: For our international medical partner, Roche Diagnostics Int Ltd based in Rotkreuz, we are looking for a qualified and motivated **Design OPS Manager** for one year with option for extension. The DesignOps Manager has the remit to increase speed and quality as the team delivers and scales. Responsible as Ops Scrum Master for operational...

  • Design Ops Manager

    vor 4 Wochen

    Rotkreuz, Schweiz Work Selection Vollzeit

    **Beschreibung**: For our international medical partner, Roche Diagnostics Int Ltd based in Rotkreuz, we are looking for a qualified and motivated **Design OPS Manager** for one year with option for extension. The DesignOps Manager has the remit to increase speed and quality as the team delivers and scales. Responsible as Ops Scrum Master for operational...