Senior Regulatory Affairs Officer

vor 2 Wochen

Genève, Schweiz Teoxane SA Vollzeit

Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore youthful volume to the face, and to treat the neck and décolleté, with natural results. The strength of Teoxane is also its human size and independence. Teoxane has a total freedom of thoughts, action and innovation which makes the company unique.

In the frame of the growth of our business, we are looking for a :

Senior Regulatory Affairs Officer (US)

Main activities

  • Provide Regulatory strategies for projects as RA representative in cross-functional teams
  • Responsible for regulatory Assessment on product changes
  • Coordinate 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 requirements
  • Coordinate the responses to questions raised by FDA
  • Review of product labelling Participate in audits and inspections, ensuring compliance with FDA requirements
  • Stay up-to-date with relevant regulations, guidelines, and industry trends, and provide strategic regulatory guidance to internal stakeholders
  • Ensure accurate population of RA databases
  • Maintain and update SOP's for Regulatory department
  • Any other specific assignment that may be entrusted to you by the Management

Your profile

  • Minimum 7 to 10 years of experience in Medical device industry
  • Proficient knowledge of quality standard (ISO 13485) and relevant regulations (21CFR part 820, MDR 2017/745) and appropriate laws, guidelines and industry standards
  • Demonstrated experience in communicating with regulatory agencies including FDA and UE regulatory agencies
  • Demonstrated experience in leading, writing and submission of complex regulatory filling (e.g. IDE, PMA, CE mark, etc-)
  • Demonstrated ability in analytical reasoning and critical thinking skills
  • Good knowledge of relevant regulations (FDA)
  • Ability to work on several projects simultaneously, ability to prioritize
  • Fluent in English with at least a B2 level in French

  • Head of Regulatory Affairs

    vor 2 Wochen

    Genève, Schweiz Teoxane SA Vollzeit

    Teoxane Laboratories were established in Geneva, Switzerland, in 2003. We are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners are able to fill all kinds of wrinkles, from the finest to the deepest, to restore youthful...

  • Head of Regulatory Affairs EU and US Medical Devices

    vor 2 Wochen

    Genève, Schweiz Axepta SA Vollzeit

    Head of Regulatory Affairs EU and US Medical DevicesNotre 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...

  • Senior RA Officer

    vor 2 Wochen

    Genève, Schweiz Axepta SA Vollzeit

    Senior RA Officer (US)Notre client, une entreprise internationale en pleine expansion spécialisée dans les dispositifs médicaux, recherche actuellement un Chargé(e) d'Affaires Réglementaires Senior (US) pour renforcer son équipe basée à Genève.  VOS RESPONSABILITÉS :Contribuer à l'élaboration de la stratégie réglementaire dans le...

  • Compliance officer

    vor 20 Stunden

    Genève, Schweiz Michael Page Switzerland Vollzeit

    Have responsibilities in relation to regulatory analysis and advisory activities, risk assessments and monitoring Compliance officer - Corporate Banking GenèveFor our client, a corporate bank in Geneva, we are currently looking for a compliance officer -100%DescriptionJob Responsibilities:Promote and monitor the effective implementation of external...

  • Senior Relationship Manager

    Vor 2 Tagen

    Genève, Schweiz FINDERS SA Vollzeit

    Senior Relationship Manager - Trusts & Fiduciary ServicesClient:Leading, global, long-established trust, private wealth & fiduciary services company. This progressive organisation is an employer of choice on the Geneva market in the trusts industry, who have an excellent reputation with clients and employees alike. A collaborative team where your own...

  • Senior Relationship Manager

    vor 20 Stunden

    Genève, Schweiz FINDERS SA Vollzeit

    Senior Relationship Manager - Trusts & Fiduciary ServicesClient:Leading, global, long-established trust, private wealth & fiduciary services company. This progressive organisation is an employer of choice on the Geneva market in the trusts industry, who have an excellent reputation with clients and employees alike. A collaborative team where your own...

  • Senior Relationship Manager

    vor 4 Stunden

    Genève, Schweiz FINDERS SA Vollzeit

    Senior Relationship Manager - Trusts & Fiduciary ServicesClient:Leading, global, long-established trust, private wealth & fiduciary services company. This progressive organisation is an employer of choice on the Geneva market in the trusts industry, who have an excellent reputation with clients and employees alike. A collaborative team where your own ideas...

  • Senior Relationship Manager

    Vor 2 Tagen

    Genève, Schweiz FINDERS SA Vollzeit

    Senior Relationship Manager - Trusts & Fiduciary ServicesClient:Leading, global, long-established trust, private wealth & fiduciary services company. This progressive organisation is an employer of choice on the Geneva market in the trusts industry, who have an excellent reputation with clients and employees alike. A collaborative team where your own...

  • Senior Legal Legacies Officer

    vor 2 Wochen

    Genève, Schweiz MEDECINS SANS FRONTIERES Suisse Vollzeit

    Senior Legal Legacies OfficerContext & MissionMédecins Sans Frontières (MSF) is an international, independent medical and humanitarian organisation that provides care to populations in need, to people affected by natural or man-made disasters and to victims of armed conflicts, without discrimination and regardless of their race, religion,...

  • Senior Legal Legacies Officer

    vor 2 Wochen

    Genève, Schweiz MEDECINS SANS FRONTIERES Suisse Vollzeit

    Senior Legal Legacies OfficerContext & MissionMédecins Sans Frontières (MSF) is an international, independent medical and humanitarian organisation that provides care to populations in need, to people affected by natural or man-made disasters and to victims of armed conflicts, without discrimination and regardless of their race, religion, belief, or...

  • Compliance Officer

    vor 4 Stunden

    Genève, Schweiz AXEPTA SA Vollzeit

    Compliance Officer / Fichier centralMain tasks / responsibilities: Central file :Analysis of account opening documentation (in compliance with CDB, AMLA, AMLO, FINMA, QI-FATCA, CRS, FINSA).Ensure the opening, updating and closing of client relationships in the core banking system (s2i).Second-level control on the scanning and archiving the documentation...

  • Office Manager

    Vor 2 Tagen

    Genève, Schweiz Page Group Switzerland Vollzeit

    We are looking for an Office Manager who will be the backbone of our client's office, ensuring the smooth and efficient running of their day-to-day activities. You will play an important role in supporting their senior management team, managing a wide range of administrative and executive tasks with a high degree of professionalism and discretion.This is a...

  • Internal audit and legal support officer

    vor 2 Wochen

    Genève, Schweiz CGA Capital Sàrl Vollzeit

    Internal audit and legal support officer - 80%The candidate will assist senior management at a Single-Family Office with accounting responsibilities, legal support and internal audits.Familiarity with accounting procedures, bookkeeping and legal structures is a must. Tasks and responsibilities:Implementation and strengthening of controlsAdministration...

  • Senior Legal Counsel

    vor 2 Wochen

    CH-1204 Genève Gunvor SA Vollzeit

    Job Title:Senior Legal Counsel - LNG, Power and Gas Contract Type:Permanent Time Type:Full time Job Description: The Senior Legal Counsel will support Gunvor’s European Gas, Power and Derivative trading activities.   Main Responsilibities Help with the day to day transactional business of the European Gas, Power and Derivatives activity of the Group ...

  • Senior Data Engineer

    vor 1 Monat

    Genève, Schweiz SGS SA Vollzeit

    We are the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,700 offices and laboratories, working together to enable a better, safer and more interconnected world. Wherever you are, whatever your industry, our experts worldwide...

  • Trust Manager H/F

    Vor 2 Tagen

    Genève, Schweiz Randstad Vollzeit

    JobdescriptionWe are looking for a Trust Manager (M/F) for our client.Job description:• Administer a diverse portfolio of trust structures (including companies) for global clients, monitoring the structures from an administrative, financial and regulatory perspective.• Providing exceptional client service, building and maintaining trust with clients,...

  • Senior SAP/ETRM Specialist

    vor 2 Wochen

    Genève, Schweiz LITASCO SA Vollzeit

    Senior SAP/ETRM SpecialistJob Purpose SummaryThe primary purpose of the Senior SAP/ETRM Specialist is to provide expertise within his/her specialized area, to implement, maintain and support related business processes in the SAP ETRM system (hereinafter referred to as the “system”), participate in the projects and change management process of the...

  • Senior SAP/ETRM Specialist

    vor 3 Wochen

    Genève, Schweiz LITASCO SA Vollzeit

    Senior SAP/ETRM SpecialistJob Purpose SummaryThe primary purpose of the Senior SAP/ETRM Specialist is to provide expertise within his/her specialized area, to implement, maintain and support related business processes in the SAP ETRM system (hereinafter referred to as the “system”), participate in the projects and change management process of the...

  • Senior Consolidation Analyst

    Vor 2 Tagen

    Genève, Schweiz SGS SA Vollzeit

    We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.    We're looking for a Senior Consolidation...

  • Compliance Officer Onboarding

    vor 2 Wochen

    Genève, Schweiz Roche Hirschy Executive Search Vollzeit

    Reconnus pour la qualité de nos dossiers, notre savoir-faire et notre accompagnement personnalisé durant les différentes phases du processus de recrutement, nous saurons être à vos côtés afin de maximiser les chances de succès de votre démarche.Grace à notre expérience des...