Jobs
>
Basel

    Regulatory Affairs - Basel, Schweiz - Straumann

    Straumann
    Straumann Basel, Schweiz

    vor 1 Woche

    Default job background
    OTHER
    Beschreibung

    Job Purpose

    Be a member of product development project-teams from the initiation phase, ensure implementation of quality and Regulatory Affairs requirements for Europe, US & Canada, perform product registration in EU, US & Canada.

    Main Tasks and Responsibilities

    • Support product development process and ensure compliance of deliverables
    • Compile the Regulatory Strategy
    • Support/Review/Approve labeling (Labels, IFU's, relevant Marketing Material) from a compliance and regulatory point of view
    • Ensure that the technical documentation supporting the CE mark complies with MDR EU 2017/745
    • Create and maintain Technical Files/ Design Dossiers for EU for MDR EU 2017/745
    • Ensure compliance with other RA relevant matters of MDR EU 2017/745 (e.g. EUDAMED, UDI, local registration CE+, information to distributors)
    • Perform conformity assessment according to MDR EU 2017/745
    • Ensure compliance with relevant US & Canadian regulations
    • Create & submit submission files for US & Canada
    • Support the International Regulatory Affairs-Team (review of Core dossier & support in registration process)
    • Support during Audits
    • Interaction with authorities, notified bodies and any other approving bodies that will be relevant
    • Support/assess change requests in accordance with MDR EU 2017/745, US & Canadian regulations
    • Assessment of potential risks and the classification of the medical device in accordance with MDR EU 2017/745, US & Canadian regulations
    • Communication of new regulatory requirements and support in implementing these.

    Profile
    Required

    • Technical or scientific graduate degree (FH/Uni/ETH) and/or minimum 4 years of professional experience in Medical Device Regulatory Affairs and/or Quality Management
    • Fluent (written and spoken) in English

    Expected

    • Detailed knowledge about the standards and norms for Medical Products such as ISO13485, ISO 14971, EU 2017/745
    • Energetic, straight forward and performance-driven professional with strong execution abilities and customer focus
    • Strong analytical skills and result-oriented
    • Effective and convincing communication, both verbally and in writing
    • Experience and appropriate technical skills including knowledge of regulatory and quality strategies to improve compliance profile.
    • Experience in the functions of Medical Device regulatory affairs and compliance: competent authority/notified body relations, compliance measures, inspections, complaints, engineering, audit processing, regulatory submissions,...
    • Experience and technical knowledge of product design, manufacturing, process for lifecycle management.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.

    Employment Type: Contract

    Alternative Locations: Switzerland : Basel

    Travel Percentage: 0 - 10%

    Requisition ID: 13104

  • Pharma-Jobs24

    Regulatory Affairs Manager

    vor 5 Tagen

    Pharma-Jobs24 Basel, Schweiz

    Sie möchten Ihre Expertise gezielt in einer neuen beruflichen Herausforderung unter Beweis stellen, um Ihr Potential voll ausschöpfen zu können? Dann gehen Sie jetzt mit uns Ihren nächsten Karriereschritt · bruederlinpartner bringt als spezialisierter Personaldienstleister jeden ...

  • HERBAMED AG

    Leitung Regulatory Affairs

    vor 1 Woche

    HERBAMED AG Basel, Schweiz

    Full Time · - Austrasse Bühler Schweiz · Wir sind ein exportorientierter Pharmahersteller im Bereich Homöopathie und Phytotherapie mit einem umfangreichen Sortiment von Wirkstoffen und Fertigarzneimitteln. Per sofort oder nach Vereinbarung · Als Abteilungsleitung sind Sie verantw ...

  • Air Liquide

    Mitarbeiterin Qualified Person, Regulatory Affairs

    vor 2 Tagen

    Air Liquide Basel, Schweiz

    **Wer sind wir? · **CARBAGAS AG **, ein Unternehmen der Air Liquide Gruppe, produziert und liefert qualitativ hochwertige Gase und anspruchsvolle Gaseanwendungen für den industriellen und medizinischen Einsatz. · Wir sind überall in Ihrem Alltag und Sie sehen es nicht Von den Bla ...

  • ProClinical

    Regulatory Affairs Manager

    vor 6 Tagen

    ProClinical Basel, Schweiz

    **Salary**: · Highly Competitive · Job type: · PermanentDiscipline: · Project Manager**Location**: · Switzerland- Basel, Schweiz · - Posting date: 27 Feb 2024 · Reference: · 57992 · Proclinical are recruiting for a Regulatory Affairs Manager - EMEA to join a pharmaceutical organi ...

  • Bruker

    Regulatory Affairs Manager

    vor 2 Tagen

    Bruker Basel, Schweiz

    Présentation: · Workload: % · Place of work: Fällanden, Switzerland · Department: Quality and Regulatory Affairs · Start of contract: Immediately or by agreement · Responsabilités: · - Team member in a team of 5 Regulatory Affairs professionals, positioned in several countries, w ...

  • Proclinical

    Regulatory Affairs Manager

    vor 6 Tagen

    Proclinical Basel, Schweiz

    Proclinical are recruiting a Regulatory Affairs Manager - CMC for a pharmaceutical organisation. This role is on a contract basis and is located in Basel. · *** · **Responsibilities**: · - Offer regulatory assistance for projects and project teams. · - Write, evaluate and offer c ...

  • CPL Recruitment

    Regulatory Affairs Manager

    vor 4 Tagen

    CPL Recruitment Basel, Schweiz

    **Posted date **15 April 2024 · **Location**Basel · **Job type** Permanent · **Salary**Negotiable · **Discipline** Life Sciences · **Reference**JO · **Work Location** Hybrid · An exciting and growing business looking to bring state-of-the-art medical technology to the market, en ...

  • CTC Resourcing Solutions

    Regulatory Affairs Manager

    vor 1 Woche

    CTC Resourcing Solutions Basel, Schweiz

    **The Life Science Career Network** · Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel thera ...

  • Universal-Job

    Regulatory Affairs Manager

    vor 1 Woche

    Universal-Job Basel, Schweiz

    In this role you are responsible for the management of the RA-owned procedural documents and mandatory training for RA GDD worldwide. Your responsibilities include: - Ensure updated and compliant status of RA-owned procedural documents (tracking and coordination of writing) - Sup ...

  • Universal-Job

    Regulatory Affairs Manager

    vor 1 Woche

    Universal-Job Basel, Schweiz

    In this position, you provide regulatory support to the portfolio transformation team, especially in divestments with a focus on data collection and implementation. Your accountabilities include: - Track progress of assigned projects, including timelines, dossier deliveries. Aler ...

  • headcount AG

    Regulatory Affairs Manager

    vor 6 Tagen

    headcount AG Basel, Schweiz Ganztags

    Bereit, die Verantwortung für Ihr Portfolio zu übernehmen? Unser Kunde, ein etabliertes Unternehmen mit einem Portfolio von Generika- und Neuro-Produkten, benötigt Ihre Hilfe, um Exzellenz im Lifecycle-Management ihrer Produkte auf dem lokalen Markt zu erreichen. Sie werden die F ...

  • bruederlinpartner

    Regulatory Affairs Manager

    vor 1 Woche

    bruederlinpartner Basel, Schweiz Ganztags

    Sie möchten Ihre Expertise gezielt in einer neuen beruflichen Herausforderung unter Beweis stellen, um Ihr Potential voll ausschöpfen zu können? Dann gehen Sie jetzt mit uns Ihren nächsten Karriereschritt · bruederlinpartner bringt als spezialisierter Personaldienstleister jeden ...

  • Jobcloud

    Regulatory Affairs Manager

    vor 1 Tag

    Jobcloud Basel, Schweiz

    Wir bieten eine spannende Stelle an unserem Hauptsitz in Basel als · Regulatory Affairs Manager 100% · Ihr Aufgabengebiet · Sicherstellung der Einhaltung von regulatorischen Anforderungen für die Entwicklung, Herstellung und Markteinführung von Medizinprodukten · Erstellung und Z ...

  • Barrington James

    Head of Regulatory Affairs, Cmc

    vor 2 Tagen

    Barrington James Basel, Schweiz

    Basel, Switzerland · - JOB TYPE · - Permanent · - EMP TYPE · - Full-Time · - EXPERTISE · - Regulatory Affairs · - SALARY TYPE · - Annually · - SALARY · - Negotiable · Position: Head of Regulatory Affairs, CMC & Drug Substances · **Responsibilities**: · - Establishing and implemen ...

  • Sobi

    International Regulatory Affairs Manager

    vor 1 Woche

    Sobi Basel, Schweiz

    **Company Description** · Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of ...

  • Sobi

    Manager, Regulatory Affairs, International

    vor 3 Tagen

    Sobi Basel, Schweiz

    **Manager, Regulatory Affairs, International** · One of Sobi's four strategic pillars is to "Go Global". The Manager, Regulatory Affairs International supports our ambitious geographical expansion plans. Sobi is seeking to register some of our existing portfolio into new territor ...

  • Hobson Prior

    Regulatory Affairs Scientific Leader

    vor 5 Tagen

    Hobson Prior Basel, Schweiz

    **Salary**: · CHF CHF130000 per annum**Job type**: · Permanent · **Location**: · Basel, Schweiz · **Function**: · Regulatory Affairs, Development · **Posted**:22/01/2024 · **Ref**: · BBBH24375 · - Hi I'm · Henry · , I manage this role · Hobson Prior are partnering with a brillian ...

  • Proclinical

    Director of Regulatory Affairs Cmc

    vor 3 Tagen

    Proclinical Basel, Schweiz

    Proclinical are recruiting a Director of Regulatory Affairs CMC - CDMO Switzerland for a pharmaceutical consultancy. This role is on a permanent basis and is located in Basel. · **Responsibilities**: · - Lead the system owners through the issuance, proposal and upkeep of all regu ...

  • Moderna Therapeutics

    Associate Director, Regulatory Affairs

    vor 5 Tagen

    Moderna Therapeutics Basel, Schweiz

    **The Role**: · Leads and continues to build the Clinical Trial Application (CTA) regulatory group, responsible for providing effective operational and regulatory support for assigned regulatory clinical trial submissions and maintenance activities, including preparation and subm ...

  • Global Personal Partner

    Regulatory Affairs Manager 100%

    vor 1 Woche

    Global Personal Partner Basel, Schweiz

    **EINFÜHRUNG**: · Our profession and our passion are "HR Management". · Global Personal is an independent company of the Interiman Group SA with over 100 employees offering a complete range of services in the field of Human Resources at 21 locations in German-speaking Switzerland ...