Regulatory Affairs Manager

vor 3 Wochen


Zug, Zug, Schweiz KMP MANAGEMENT CONSULTING Vollzeit
Aufgaben

Als Regulatory Affairs Manager sind Sie für die Einhaltung der regulatorischen Anforderungen für Medizinprodukte verantwortlich. Sie müssen sicherstellen, dass Produkte und Prozesse den neuen und existierenden regulatorischen Anforderungen entsprechen.

  • Identifizierung von anwendbaren regulatorischen, legalen und anderen externen Anforderungen in Bezug auf Medizinprodukte
  • Etablierung eines Corporate Office zur zentralen Koordination der Erstellung/Aufrechterhaltung von regulatorisch-konformen Kennzeichnungsmaterialien für Medizinprodukte
  • Beurteilung der Produkte auf deren Risikopotential
  • Unterstützung bei der Erstellung von zulassungsrelevanten Dokumenten für die weltweite Registrierung von FME Medizinprodukten
  • Planung, Dokumentation, Monitoring, Reporting und Nachverfolgung von Projekten im regulatorischen Bereich des Medizinprodukte-, Qualitätsmanagementsystems
  • Mithilfe bei der Realisierung von klinischen Bewertungen und Marktüberwachungen (post market surveillance)
  • Intensive Kommunikation mit internen Fachabteilungen, Kooperationspartnern und Zulassungsstellen weltweit
Qualifikation
  • Erfolgreich abgeschlossenes Studium im wissenschaftlichen, medizinischen oder technischen Bereich oder vergleichbare Ausbildung
  • Mehrjährige Berufserfahrung als Spezialist im Regulatory Affairs und/oder Qualtitätsmanagement vorzugsweise in branchennahen Unternehmen mit internationaler Ausrichtung
  • Sehr gute Kenntnisse der Regularien für Medizinprodukte
  • Gute analytische Fähigkeiten
  • Sicher in der Umsetzung von Moderations- und Präsentationstechniken
  • Proaktives und lösungsorientiertes Vorgehen
  • Sehr gute Deutsch- und Englischkenntnisse, jede weitere Fremdsprache ist vom Vorteil
Benefits
  • Eine interessante Aufgabe in einem innovativen, international tätigen Familienunternehmen
  • Eine Unternehmenskultur, in der es Spass macht Ideen, Kraft und Initiative einzubringen
  • Mitarbeit in einem engagierten Team
  • Flache Hierarchien und kurze Kommunikationswege
  • Überdurchschnittliche Sozialleistungen

Wenn Sie sich angesprochen fühlen, so möchten wir Sie gerne kennenlernen. Senden Sie uns bitte Ihre vollständigen Bewerbungsunterlagen einschließlich Foto und Angabe Ihres frühestmöglichen Eintrittstermins sowie Ihrer Gehaltsvorstellungen.



  • Zug, Zug, Schweiz KMP MANAGEMENT CONSULTING Vollzeit

    Aufgaben und VerantwortlichkeitenAls Regulatory Affairs Manager sind Sie für die Einhaltung der regulatorischen Anforderungen für Medizinprodukte verantwortlich. Sie müssen sicherstellen, dass Produkte und Prozesse den neuen und existierenden regulatorischen Anforderungen entsprechen.Qualifikationen und ErfahrungenErfolgreich abgeschlossenes Studium im...


  • Zug, Zug, Schweiz KMP MANAGEMENT CONSULTING Vollzeit

    AufgabenAls Regulatory Affairs Manager sind Sie für die Einhaltung der regulatorischen Anforderungen für Medizinprodukte verantwortlich. Sie müssen sicherstellen, dass Produkte und Prozesse den neuen und existierenden regulatorischen Anforderungen entsprechen.Identifizierung von anwendbaren regulatorischen, legalen und anderen externen Anforderungen in...


  • Zug, Zug, Schweiz Gilead Sciences Switzerland Sarl Vollzeit

    Job Title: Senior Manager, Regulatory Affairs CMCGilead Sciences Switzerland Sarl is seeking a highly skilled and experienced Senior Manager, Regulatory Affairs CMC to join our team in Zug, Switzerland.Job Summary:The CMC Regulatory Affairs International Affiliate Team is responsible for ensuring compliance with regulatory requirements for CMC activities in...


  • Zug, Zug, Schweiz Johnson & Johnson Vollzeit

    Job Title: Regulatory Affairs ManagerJohnson & Johnson is seeking a highly motivated and experienced Regulatory Affairs Manager to join our local Regulatory Affairs team located in Zug, Switzerland. This role will be working in a hybrid working model.About Johnson & JohnsonAt Johnson & Johnson, we believe health is everything. Our strength in healthcare...


  • Zug, Zug, Schweiz AbbVie Vollzeit

    Job SummaryThe Regulatory Affairs Coordinator will be responsible for managing the label lifecycle, regulatory budget, and reporting topics within the Regulatory Affairs department. This role will also provide support in the handling of Medical Devices and ensure compliance with local regulatory requirements.Key ResponsibilitiesLabel ManagementPrepare,...


  • Zug, Zug, Schweiz Gilead Sciences Switzerland Sarl Vollzeit

    About the RoleGilead Sciences Switzerland Sarl is seeking a highly skilled and experienced Regulatory Affairs Senior Manager to join our team in Zug, Switzerland. As a key member of our CMC Regulatory Affairs International Affiliate Team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to meet business...


  • Zug, Zug, Schweiz Gilead Sciences Switzerland Sarl Vollzeit

    Job Title: Senior Manager, Regulatory Affairs CMCGilead Sciences Switzerland Sarl is seeking a highly skilled and experienced Senior Manager, Regulatory Affairs CMC to join our team in Zug, Switzerland.Job Summary:The CMC Regulatory Affairs Senior Manager will be responsible for leading the development and implementation of regulatory strategies for CMC...


  • Zug, Zug, Schweiz NonStop Consulting Vollzeit

    Regulatory Affairs Director OpportunityNonStop Consulting is seeking an experienced Regulatory Affairs Director to join our team in Europe. As a key member of our Regulatory Affairs team, you will be responsible for leading European regulatory operations, ensuring compliance, and developing and maintaining procedures.About the RoleLead European Regulatory...


  • Zug, Zug, Schweiz Gilead Sciences Switzerland Sarl Vollzeit

    About the RoleGilead Sciences Switzerland Sarl is seeking a highly experienced Regulatory Affairs Manager to join our CMC Regulatory Affairs International Affiliate Team in Zug, Switzerland. As a key member of our team, you will be responsible for CMC activities in Switzerland and Israel, collaborating with Global teams to design and execute CMC RA...


  • Zug, Zug, Schweiz NonStop Consulting Vollzeit

    About Our ClientOur client is a leading regulatory affairs team with a diverse portfolio of iconic brands across 20 countries. They operate in Australia & New Zealand, Asia, and Africa, and are dedicated to putting people's health first every day.The OpportunityWe are seeking an experienced Associate Regulatory Affairs Director, Europe, to become an integral...


  • Zug, Zug, Schweiz Gilead Sciences Switzerland Sarl Vollzeit

    Position OverviewGilead Sciences Switzerland Sarl is seeking a seasoned professional to join our CMC Regulatory Affairs team as a Senior Manager. This role will focus on managing CMC regulatory responsibilities for designated regions.Role SummaryThe Senior Manager of CMC Regulatory Affairs is integral to the Global CMC RA organization, acting as the primary...


  • Zug, Zug, Schweiz Gilead Sciences Switzerland Sarl Vollzeit

    Position OverviewGilead Sciences Switzerland Sarl is seeking a seasoned professional to join our CMC Regulatory Affairs International Affiliate Team as a Senior Manager in Zug, Switzerland. This role focuses on CMC activities within Switzerland and Israel.Role SummaryThe Senior Manager for CMC Regulatory Affairs plays a crucial role within the Global CMC RA...


  • Zug, Zug, Schweiz Hologic, Inc. Vollzeit

    Empowering Women's Health Through Regulatory ExcellenceHologic, Inc. is seeking a highly skilled Senior Director, Regulatory Affairs to join our team. As a leading innovator in women's health, we are committed to delivering innovative solutions that improve lives.The successful candidate will be responsible for leading our international regulatory affairs...


  • Zug, Zug, Schweiz Gilead Sciences Switzerland Sarl Vollzeit

    About the RoleGilead Sciences Switzerland Sarl is seeking a highly motivated and experienced Regulatory Affairs Senior Manager to join our team in Zug, Switzerland. As a key member of our CMC Regulatory Affairs International Affiliate Team, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to support the...


  • Zug, Zug, Schweiz Gilead Sciences Switzerland Sarl Vollzeit

    Job OverviewGilead Sciences Switzerland Sarl is seeking a highly skilled Regulatory Affairs Professional to assume a full-time employment position in Zug, Switzerland. As a Senior Manager for Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs, you will be responsible for CMC activities in Switzerland and Israel.Key ResponsibilitiesPrepare CMC...


  • Zug, Zug, Schweiz Gilead Sciences Switzerland Sarl Vollzeit

    About the RoleGilead Sciences Switzerland Sarl is seeking a highly experienced Regulatory Affairs Senior Manager to join our CMC Regulatory Affairs International Affiliate Team in Zug, Switzerland. As a key member of our Global CMC RA organization, you will serve as the CMC RA Affiliate for assigned products and territories, collaborating with Global teams...


  • Zug, Zug, Schweiz Congo Brands Vollzeit

    About Congo BrandsCongo Brands is a leading health and wellness company that offers a diverse range of supplements, fitness snacks, hydration drinks, and energy drinks through e-commerce and retail partnerships.The company houses several notable brands, including Alani Nu, Prime Hydration, Prime Energy, and 3D Energy, with plans to expand its portfolio in...


  • Zug, Zug, Schweiz Viatris Vollzeit

    About the RoleWe are seeking a highly skilled and experienced Director of Regulatory Affairs to lead our Swiss Regulatory Team. As a key member of our organization, you will be responsible for delivering against or bettering expectations from regulatory stakeholders and ensuring close alignment with relevant Commercial Teams.Key ResponsibilitiesLead the...


  • Zug, Zug, Schweiz Viatris Vollzeit

    About the RoleWe are seeking a highly skilled and experienced Director of Regulatory Affairs to join our team in Switzerland. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with Swiss national regulations and regulatory guidance, policies, and procedures.Key ResponsibilitiesLead the Swiss Regulatory Team by...


  • Zug, Zug, Schweiz Viatris Vollzeit

    About the RoleViatris is seeking a highly skilled and experienced Director of Regulatory Affairs to lead our Swiss Regulatory Team. As a key member of our global regulatory team, you will be responsible for delivering against or bettering expectations from regulatory stakeholders and ensuring close alignment with relevant Commercial Teams.Key...