Regulatory Affairs Manager for Medical Devices

vor 6 Monaten


Winterthur, Schweiz Acrostak Vollzeit

Acrostak is active in development, manufacturing and distribution of medical devices used for interventional cardiology. Our products comprise different types of angioplasty catheters to open occluded vessels as well as other high-tech devices in the field of mínimally invasive interventions. In order to strengthen our team in **Winterthur**, Switzerland, we are looking for a

**Regulatory Affairs Manager for medical devices**

**_Your profile: _**:

- _
- Bachelor’s or master’s degree in law, medicine, engineering or other relevant life science field
- Languages: English (main), German (is an asset)
- Experience of minimum 5 years in the regulatory field for medical devices (with adequate knowledge of QMS/ ISO 13485 requirements)
- Good knowledge of MDR 2017/745. Experience with submissions to Notified Bodies
- Good knowledge of USA regulatory system (e.g. direct involvement in 510K submissions)
- Knowledge of regulatory systems of other countries strongly appreciated (e.g. China,

Latin America, Japan etc.)
- Strong problem-solving skills
- Strong interpersonal skills
- Proactive and sales-oriented attitude
- Wish to work in an environment where there is room for optimization and improvement
- Ability to work independently
- Ability to understand and summarize technical and clinical data
- Ability to manage projects
- Computer literacy skills
- Good written and verbal communication
- Swiss nationality or Permit B or C or European citizen

**_Your tasks and responsibilities: _**:

- _
- Register new products in different regulatory systems directly with the local health authorities
- Write SOPs to improve processes
- Develop strategies for the most efficient registration pathways
- Monitor regulatory requirements worldwide
- Maintain current registrations worldwide and improve them as necessary
- Communicate with regulatory bodies
- Improvement and optimization RA department
- Research regulatory requirements and advise other departments of such requirements
- Complaints management, post-market surveillance, labelling requirements, distributorships, involvement in clinical aspects
- Working in collaboration with different departments, mainly QA
- Support S&M with specific regulatory needs from distributors/importers

Type d'emploi : 100%

Salaire : CHF100'000.00 à CHF150'000.00 par an

Programmation:

- Du Lundi au Vendredi
- Période de travail de 8 Heures
- Travail en journée

Formation:

- Baccalauréat universitaire (Exigé)

Expérience:

- MedTech RA (QMS/ ISO 13485, MDR, US 510K, Not Bodies): 5 ans (Exigé)

Langue:

- English (main), German (is an asset) (Exigé)

Permis/certificat:

- Degree in medicine, engineering, other life science (Exigé)
- Swiss nationality or Permit B or C or European citizen (Exigé)

Lieu du poste : En présentiel


  • Regulatory Legal Counsel

    vor 2 Monaten


    Winterthur, Schweiz SWICA Gesundheitsorganisation Vollzeit

    **Regulatory Legal Counsel (alle)**: **80-100% in Winterthur**: Qualität kommt nicht von ungefähr, sondern von deinen 2000 gut ausgebildeten Arbeitskolleginnen und Arbeitskollegen, die ganzheitliche Gesundheit als Dienstleistung am Menschen verstehen. Du kannst dich auf sie verlassen. Sie sind Profis wie du. Alle ziehen am gleichen Strick; das ist ein...

  • Regulatory Legal Counsel

    vor 2 Monaten


    Winterthur, Schweiz SWICA Gesundheitsorganisation Vollzeit

    Regulatory Legal Counsel (alle) 80-100% in Winterthur Qualität kommt nicht von ungefähr, sondern von deinen 2000 gut ausgebildeten Arbeitskolleginnen und Arbeitskollegen, die ganzheitliche Gesundheit als Dienstleistung am Menschen verstehen. Du kannst dich auf sie verlassen. Sie sind Profis wie du. Alle ziehen am gleichen Strick; das ist ein gutes...


  • Winterthur, Schweiz Care Preventive AG Vollzeit

    CARE is committed to the long-term health of patients through advanced analysis and treatment methods in the fields of preventive medicine and longevity. In our modern, centrally located practices, we offer a unique experience and work with the most modern methods of preventive medicine. Based on medical history and laboratory diagnostics, we recommend...


  • Winterthur, Zürich, Schweiz kessler gmbh Vollzeit

    We are seeking a highly skilled Senior Portfolio Manager to join our team at Kessler GmbH. This is a challenging role that requires strong analytical and organizational skills, as well as excellent communication abilities.Job SummaryThe Senior Portfolio Manager will be responsible for the management and oversight of investment portfolios, ensuring alignment...


  • Winterthur, Zürich, Schweiz ZHAW Vollzeit

    Job DescriptionWe are seeking a highly motivated Electrical Engineer to join our team at ZHAW in the field of perovskite solar cell modeling. This is a unique opportunity to contribute to the development of numerical simulations for perovskite semiconductor devices.Key Responsibilities:Develop and implement numerical device modeling software to simulate the...


  • Winterthur, Zürich, Schweiz WinGD – Winterthur Gas & Diesel Vollzeit

    Main Responsibilities:As a highly skilled Account Manager for Electrification Solutions, you will be responsible for managing and nurturing relationships with our esteemed clients, including shipowners and shipyards. You will drive the sales of our advanced integrated systems and lifecycle services. The ideal candidate will have a strong background in...


  • Winterthur, Zürich, Schweiz Kessler Gmbh Vollzeit

    About the RoleWe are seeking a seasoned Wealth Management professional to lead our team in Zurich, focusing on high-net-worth clients from the Netherlands, Belgium, and Luxembourg. As Teamhead Relationship Manager, you will be responsible for managing an existing client portfolio and developing new business opportunities.Main Responsibilities:Take ownership...


  • Winterthur, Zürich, Schweiz Burckhardt Compression AG Vollzeit

    Job OverviewWe are seeking an experienced Senior Electrical Engineering Team Manager to lead our team of electrical engineers in the development and implementation of innovative solutions for industrial applications.Responsibilities:Manage a team of electrical engineers, providing guidance, support, and direction to ensure project delivery and team...


  • Winterthur, Schweiz Kessler.vogler Gmbh Vollzeit

    Job profile Build expertise in taxation requirements, processes, and systems for diverse transactional and positional tax obligations Analyse and improve controls or processes related to tax operations Collaborate with the global team to execute key tax reform programs (e.g., FATCA and CRS), assess their impact, and ensure smooth implementation Monitor the...


  • Winterthur, Schweiz Kessler.vogler Gmbh Vollzeit

    Job profile Build expertise in taxation requirements, processes, and systems for diverse transactional and positional tax obligations Analyse and improve controls or processes related to tax operations Collaborate with the global team to execute key tax reform programs (e.g., FATCA and CRS), assess their impact, and ensure smooth implementation Monitor the...


  • Winterthur, Schweiz coatmaster AG Vollzeit

    Your role Develop and execute the market strategy for East Asia (China, Japan, Korea, and potential future markets).Build and support distribution partnerships, including sales and technical repairs and integration enablement.Manage and coach local sales engineers to achieve targets and ensure customer satisfaction.Handle key accounts in collaboration with...


  • Winterthur, Zürich, Schweiz ZHAW Vollzeit

    Advanced Materials Characterization PhD OpportunityWe are seeking a highly motivated and skilled PhD researcher to join our team at the Zurich University of Applied Sciences (ZHAW) in Switzerland.About the RoleThis PhD project is focused on characterizing perovskite semiconductor devices on the nanoscale using atomic force microscopy. The goal is to relate...


  • Winterthur, Schweiz ZHAW Vollzeit

    Your role Your PhD work is embedded into a project funded by the Swiss National Science Foundation. Topic of this project is to develop numerical simulations for perovskite semiconductor devices that allow to describe the results of AFM-based nanoscale...


  • Winterthur, Schweiz Burckhardt Compression Vollzeit

    Anforderungs-ID: 4320- Job Type: Hybrid- Standort: Winterthur, Zürich, CH- Datum: 05.09.2024For our organization in the new machine business, we are looking for an initiative and committed person to strengthen our team as **Project Manager for global Projects (f/m/d) 80 - 100%** **Your daily contribution**: - Responsible for commercial and technical...


  • Winterthur, Schweiz kessler.vogler gmbh Vollzeit

    A successful organisation operating in the banking sector is currently searching for a committed Teamhead Relationship Manager to join the sales and customer consulting team in Zurich. In your new role, you will provide comprehensive advice to clients and manage a small team of RMs..Your main responsibilities as a Relationship Manager will be: Takeover of an...


  • Winterthur, Schweiz Kessler.vogler Gmbh Vollzeit

    Job profile Assist in the management and oversight of investment portfolios, ensuring alignment with clients' objectives and risk profiles Prepare detailed reports, performance analyses, and presentations for internal and client use Support the research and analysis of financial markets, investment products, and trends to identify opportunities and risks...

  • Android Team Manager

    vor 8 Monaten


    Winterthur, Schweiz wallee AG Vollzeit

    Wallee is a payment technology company that enables merchants to accept omnichannel payments - whether online in web shops, on mobile devices, unattended kiosks or in physical outlets with terminals. Our software engineers are working on a variety of projects ranging from big data systems to dedicated merchant integrations. We’re driven by constantly...


  • Winterthur, Schweiz Center for Student Achievement Solutions Vollzeit

    CBRE Data Centre Solutions (DCS) is a part of the CBRE Group with over 115.000 employees worldwide and delivers fully integrated real estate, facilities and technology solutions for data centre owners, occupiers and investors across the globe. As a dedicated business line within CBRE, DCS is dedicated to solving complex challenges within every stage of...


  • Winterthur, Schweiz ZHAW Vollzeit

    Your role Your PhD work is embedded into a project funded by the Swiss National Science Foundation. Topic of this project is to characterize perovskite semiconductor devices on the nanoscale using atomic force microscopy. The goal is to clearly relate nanoscale...


  • Winterthur, Schweiz kessler.vogler gmbh Vollzeit

    A successful organisation operating in the banking sector is currently searching for a committed Teamhead Relationship Manager to join the sales and customer consulting team in Zurich. In your new role, you will provide comprehensive advice to clients and manage a small team of RMs..Your main responsibilities as a Relationship Manager will be: - Takeover of...