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



  • Rotkreuz, Schweiz Manpower Vollzeit

    Contract type Temporär - 1 year, with possibility of extensionPlace - RotkreuzReference manager-6155-577126Assignment start date sap - latest Start Date: 1 September 2023Sector Chemie & Life SciencesPublication date 21.07.2023Apply Regulatory Project Manager Your assignment - Tasks & Responsibilities: - Manages regulatory responsibilities associated...


  • 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 development and implementation of regulatory strategies and plans to support the timely introduction of new products and...


  • 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...


  • 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,...


  • 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,...


  • Rotkreuz, Schweiz Manpower Vollzeit

    **Your mission** For one of our clients, a leading global pharma company in Rotkreuz near Zürich, we are currently looking for a **Regulatory Affairs Manager.** - Start date: 01.02.2023 - latest start date: 01.03.2023 - End date: 2 years but may need to extend - Extension: Possible - Workload: 70-100% - Home Office: hybrid - Travel: 10% (just in case of a...


  • Rotkreuz, Schweiz Manpower Suisse Vollzeit

    **General Information**: - Start date: asap - latest Start Date: 1 September 2023 - End date: 1 year - Extension: yes - Workplace: ROTKREUZ - Workload: 100% - Remote/Home Office: Minimum 1 day a week on-site - Travel: 5% possibly international travel (maximum 1 a year) - Fixed working hours y/n: yes **Tasks & Responsibilities**: - Manages regulatory...


  • 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...


  • Rotkreuz, Zug, 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: 70100% Home Office: hybrid Flexible working hours Travel: 10% (just in...


  • Rotkreuz, Zug, Schweiz Manpower Suisse Vollzeit

    General Information: Start date: asap- latest Start Date: 1 September 2023 End date: 1 year Extension: yes Workplace: ROTKREUZ Workload: 100% Remote/Home Office: Minimum 1 day a week on-site Travel: 5% possibly international travel (maximum 1 a year) Fixed working hours y/n: yesTasks & Responsibilities: Manages regulatory responsibilities associated with the...


  • 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 4 Wochen


    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,...


  • 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...


  • 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 4 Wochen


    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

    vor 3 Wochen


    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,...


  • Rotkreuz, Zug, Schweiz Amgen Vollzeit

    HOW MIGHT YOU DEFY IMAGINATION?:If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better...


  • Rotkreuz, Schweiz Amgen Vollzeit

    **HOW MIGHT YOU DEFY IMAGINATION?**: If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering...


  • Rotkreuz, Zug, Schweiz Coopers Group AG Vollzeit

    Global Project ManagerFor our client, a leading company in the MedTech field, we are currently looking for a Global Project ManagerTasks and Responsibilities: Orchestrates and leads SAFe practices, guides the Agile Release Train (ART) through strategic alignment and PI planning, ensures successful PI execution, coaches ART roles, optimizes flow by...

  • Global Project Manager

    vor 2 Monaten


    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 **Global Project Manager** for one year with option for extension. Roche Diagnostics International Ltd is one of the world’s leading providers of diagnostic system solutions for clinics, laboratories and...