Head of Regulatory Affairs EU and US Medical Devices

vor 3 Wochen


Geneva, Schweiz Axepta SA Vollzeit

Notre client, une société de dispositifs médicaux de niche en pleine croissance, recherche un Head of Regulatory Affairs (QP) EU et US pour rejoindre son bureau de Genève.

Cette position offre une expertise stratégique et un leadership à ses partenaires commerciaux et parties prenantes (y compris la R&D, la Clinique, la Qualité et le Marketing).

Responsabilités :

·         Élaborer la feuille de route stratégique réglementaire selon les objectifs commerciaux et fournir un leadership réglementaire pour les programmes dans l'espace pré et post-marché.

·         Fournir un mentorat stratégique pour garantir l'alignement des stratégies réglementaires avec les objectifs commerciaux et la mise en ?uvre des plans stratégiques.

·         Contribuer aux décisions stratégiques clés impactant le développement des processus et procédures de conformité réglementaire globale.

·         Suivre la mise en ?uvre des nouvelles exigences de l'UE et des États-Unis à travers le processus d'intelligence réglementaire et adapter la stratégie en conséquence.

·         Contribuer à la stratégie réglementaire dans le cadre du développement de nouveaux produits en collaboration avec des équipes pluridisciplinaires en définissant les voies réglementaires et en développant des stratégies réglementaires pour soumission aux Organismes Notifiés et à la FDA.

·         Superviser la compilation des dossiers de soumission réglementaire pour les nouveaux produits et les modifications de produits pour obtenir des soumissions/approbations en temps opportun (y compris les IDE et les PMA).

·         Contribuer et examiner les réponses aux questions posées par l'Organisme Notifié et la FDA pour garantir des réponses appropriées, cohérentes et complètes à toute question.

·         Soutenir les activités de gestion du cycle de vie (y compris l'évaluation de l'impact réglementaire des changements de contrôle pour les régions de l'UE et des États-Unis).

·         Garantir la conformité des produits avec les réglementations et normes de l'UE et des États-Unis.

·         Garantir l'excellence des Affaires Réglementaires en soutenant l'établissement, la maintenance et l'optimisation des processus et procédures des Affaires Réglementaires afin d'assurer l'amélioration continue du QMS

·         Assurer une communication efficace au sein de l'équipe mondiale des Affaires Réglementaires.

·         Mentorer, former, superviser l'équipe des Affaires Réglementaires dédiée aux régions de l'UE et des États-Unis en les habilitant à interagir et à négocier avec les régulateurs.

 

Exigences et compétences :

·       Diplôme et l'expérience pour agir en tant que Deputy PRRC.

·       Minimum 10 ans d'expérience dans des fonctions similaires.

·       Expérience en Affaires Réglementaires dans le domaine des dispositifs médicaux (dispositifs médicaux à haut risque) avec une connaissance approfondie des réglementations de l'UE et des États-Unis et un fort leadership avec au moins une expérience de gestion d'équipe.

·       Grande capacité à prendre en charge et à assumer la responsabilité des actions.

·       Capacité à résoudre les problèmes et à prendre des décisions réglementaires.

·       Expérience dans la négociation avec les agences réglementaires et l'Organisme Notifié.

·       Démontrer des compétences pour gérer plusieurs projets simultanément.

·       Capacité à travailler dans un environnement dynamique.

·       Parle couramment anglais et français

 

 



Branche: Medizin/Krankenhaus

Funktion: Qualitätsprüfung

Führungsperson: Ja

Anstellungsart: Festanstellung

Karrierestufe: Management





  • Geneva, Schweiz Michael Page Vollzeit

    Mentor, train, and supervise Regulatory Affairs teams, ensuring effective collaboration with other departments.Monitor and interpret changes in international regulations.Develop and implement regulatory strategy aligned with the company's business objectives, in collaboration with other departments.Supervise the preparation and submission of registration...


  • Geneva, Schweiz SGS Vollzeit

    Job Description Primary Responsibilities As the Medical Device Lead Auditor, you will perform third-party audits per SGS Certification procedures and the requirements for ISO 13485, MDSAP, MDD and MDR standards. The Medical Device Lead Auditor is responsible to make relevant decisions concerning the audit process and to inform SGS as required to...


  • Geneva, Schweiz Michael Page Switzerland Vollzeit

    To enhance our client's Legal team, we seek a Legal Counsel to support the Group Head of Legal in overseeing diverse legal and compliance affairs while offering valuable assistance to their business operations.Legal Counsel, pharma/medical devices - 100% FR/ENG (m/f/d)International company based in Geneva.DescriptionEngage in the drafting, evaluation, and...


  • Geneva, Schweiz WHO Vollzeit

    DESCRIPTION OF DUTIES Under the general supervision of the Director, Innovation and Access to Medicines and Health Technologies (IMT) and the direct supervision of the of the Chief, Special Program, Innovation and the Regional Production Platform (IMT/RP), the incumbent is responsible for, but not necessarily limited to, the following assigned duties: ...


  • Geneva, Schweiz Michael Page Vollzeit

    Provide Regulatory strategies for projects as RA representative in cross-functional teamsResponsible for regulatory Assessment on product changesCoordinate the preparation of regulatory submissions (such as IDE, original PMA and supplements)in the context of new product and product changes in accordance with FDA requirementsCoordinate the responses to...

  • EU Sustainability Lead

    vor 4 Wochen


    Geneva, Schweiz CHS Vollzeit

    CHS Inc. is a leading global agribusiness owned by farmers, ranchers and cooperatives across the United States that provides grain, food and energy resources to businesses and consumers around the world. We serve agriculture customers and consumers across the United States and around the world. Most of our 10,000 employees are in the United States, but...


  • Geneva, Schweiz Albedis Vollzeit

    INTRODUCTION: For one of our client in the consumer health industry, we are looking to hire a candidate strongly interested in Regulatory Affairs, with experience in medicinal products.DESCRIPTION DE LA MISSION: As the Regulatory Affairs Specialist, you will play a critical role in enabling the PHC business for the relevant portfolio within and outside...


  • Geneva, Schweiz Michael Page Vollzeit

    The Head of Finance and Administration provides leadership to key organisational functions, including financial management, donor compliance, administration, HR and governance, working towards a collaborative and positive culture for the smooth functioning of the organization.Strategic and business operationsSupport the compilation of the annual workplan and...


  • Geneva, Schweiz MSC CRUISES Vollzeit

    JOB PURPOSE MSC Cruises is seeking an experienced professional in Legal Compliance to join the Corporate Legal Group based in Geneva. As a key member of the team, you will collaborate with other legal colleagues, fostering a culture of teamwork, empathy, and curiosity. As the Head of Corporate Compliance, you will play a vital role in developing and...


  • Geneva, Schweiz Michael Page Vollzeit

    Design the Bank's ALM strategy based on its business strategy, risk appetite and projected scenarios regarding capital, liquidity and interest rates;Maximize treasury income through innovative investment strategies;Upgrade forecasting tools for regulatory ratios;Continuously update capital, liquidity and interest-rate scenarios;Monitor regulatory...

  • Head of Finance

    vor 3 Wochen


    Geneva, Schweiz CHS Alliance Vollzeit

    Are you an experienced Finance professional willing to make a difference in the humanitarian sector? Do you want to join a small and dynamic organisation? If so, we would love to hear from you. Time commitment : Full time role Location : Geneva (other locations explored for the right candidate) Salary : Between 115’249 CHF and 131’713 CHF...


  • Geneva, Schweiz Michael Page Vollzeit

    Engage in the drafting, evaluation, and negotiation of a broad spectrum of agreements (e.g., distribution and licensing agreements, manufacturing agreements, IT agreements, R&D-related agreements).Manage the drafting, review, and upkeep of various legal and corporate documents (e.g., PoAs, Resolutions, Meeting Minutes).Foster collaboration with external...

  • Head of Market

    vor 3 Wochen


    Geneva, Schweiz Symbiotics Vollzeit

    About the Job * Job description Lead a team of 7 specialists based in Geneva and London, overseeing credit, market and ESG risk assessment and monitoring for both core-business (financial institutions) and innovation sectors (fintech, clean energy, corporate lending, agri-business, project finance). Organize and participate in Credit Committees. ...

  • Head of Finance

    vor 1 Woche


    Geneva, Schweiz Page Executive Vollzeit

    About Our Client Established in 1947, the International Organization for Standardization (ISO) is a prominent non-governmental organization spanning 171 countries based in Geneva. ISO's mission is to foster global trade and collaboration by developing International Standards across various fields. With a vast portfolio of over 25,000 standards, ISO ensures...


  • Geneva, Schweiz World Economic Forum Vollzeit

    The World Economic Forum’s Centre for the New Economy and Society (CNES) is the global platform for shaping prosperous, inclusive and equitable economies and societies that create opportunity for all. The work of CNES is described , and accelerates impact on five interconnected Missions, including Education, Skills and Learning As the Head of the ...


  • Geneva, Schweiz Epam Vollzeit

    Description About the role EPAM is searching for a dynamic Head of Cloud Security to lead in Geneva and enhance our strategic cloud security operations. This role offers an exceptional opportunity to assume the helm of our Cloud Security department, driving strategy, overseeing threat management and ensuring robust security protocols for our...


  • Geneva, Schweiz Bottomline Vollzeit

    RoleWe are looking for a Head of GT Software Development to innovate, win and grow with us in Geneva! Work with the Development teams on Bottomline’s exciting and innovative Financial Messaging solution. As Head of GT Suite Software Development, you’ll lead teams to success, driving them to deliver critical, high quality, secured software. Position...

  • Sanctions Officer

    vor 3 Wochen


    Geneva, Schweiz Michael Page Vollzeit

    Stay abreast of regulatory updates from various authorities (e.g., US OFAC, UN Security Council, Swiss SECO, UK OFSI, Council of the EU etc.) in relation to commodities trading and shipping industry.Offer compliance guidance to the commercial team regarding cross-border transactions, with a focus on regulatory compliance, and assist in conducting transaction...

  • Head of Product

    vor 3 Wochen


    Geneva, Schweiz Mina Foundation Vollzeit

    We’re seeking a Head of Product who can navigate the interdisciplinary tradeoffs that come with using cryptography and zk-Snarks, a novel technology in the world of blockchains, to build decentralized computing systems that put people back in control of their digital lives.Mina Foundation is a public benefit corporation serving the Mina Protocol, the...

  • Head of Cross-Media

    vor 2 Wochen


    Geneva, Schweiz TVZ Vollzeit

    Job Vacancy:  Head of Cross-Media - ICRC Location:  Geneva, Switzerland Closing Date: 22nd May 2024 Context The Head of Cross-Media is a senior management position within the communication division at ICRC headquarters in Geneva. Together with other communication leaders, the postholder will play a key role in implementing the...