Regulatory Affairs Specialist

vor 4 Wochen

Berlin, Berlin, Deutschland Olympus Vollzeit

About the Role

The Regulatory Affairs Manager at Olympus is responsible for ensuring compliance of Digital Unit products with international regulations, providing regulatory guidance, and maintaining expertise in evolving industry standards.

Key Responsibilities

  • Ensure Digital Unit products comply with regulatory requirements for key markets.
  • Provide regulatory oversight and guidance to development teams, focusing on AI, Software as a Medical Device (SaMD), and Machine Learning.
  • Support compliance for launched products with Olympus Regulatory Affairs.
  • Respond to regulatory body inquiries and manage communications with international agencies.
  • Maintain expert knowledge of relevant regulations and assess the impact of legislative changes.
  • Collaborate with stakeholders to develop strategies that address regulatory updates and ensure compliance.
  • Manage third-party vendors as required.
  • Collaborate with cross-functional teams to drive regulatory strategy and innovation.

Requirements

  • University degree in relevant fields with 2+ years of Regulatory Affairs experience in the medical device industry.
  • Expertise in SaMD, Class I/II/III medical devices, and AI/ML-enabled technologies.
  • Experience with international regulators (FDA, Notified Bodies) and agile development teams.
  • Strong ability to align digital, business, and R&D leadership on regulatory needs.
  • Collaborative mindset, excited to work with cross-functional teams and embrace change.
  • Comfortable challenging the status quo and providing strategic direction.
  • Excellent problem-solving, communication, and English language skills (written and verbal).

What We Offer

  • 30 days of annual leave
  • Up to 60% mobile work possible + flexible work time model with overtime compensation
  • Holiday and Christmas bonuses
  • Corporate benefits discounts for employees
  • Comprehensive company pension scheme and capital-forming benefits
  • Company restaurant with live cooking and healthy food (subsidized)
  • Employee Assistance Program of FamPLUS to support your health, mental and emotional well-being
  • Subsidy for public transportation (Deutschlandticket), free parking spaces and bike or car leasing
  • Various subsidized company sports groups and access to the inhouse company gym

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Berlin, Berlin, Deutschland GULP – experts united Vollzeit

    JobbeschreibungWir suchen einen Regulatory Affairs Specialist für unseren Standort in Berlin.Ihre AufgabenPlanung, Organisation und Durchführung von nationalen Verfahren zur Neuzulassung, Zulassungsverlängerung sowie zur Zulassungsänderung von ArzneimittelnMitarbeit an entsprechenden europäischen Verfahren (MRP, DCP, CP) für Arzneimittel in enger...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Berlin, Berlin, Deutschland GULP – experts united Vollzeit

    JobbeschreibungWir suchen einen Regulatory Affairs Specialist für unseren Standort in Berlin.Ihre AufgabenPlanung, Organisation und Durchführung von nationalen Verfahren zur Neuzulassung, Zulassungsverlängerung sowie zur Zulassungsänderung von ArzneimittelnMitarbeit an entsprechenden europäischen Verfahren (MRP, DCP, CP) für Arzneimittel in enger...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Berlin, Berlin, Deutschland Parexel Vollzeit

    Parexel is seeking a highly skilled Regulatory Affairs Consultant to join our team.The ideal candidate will have expertise in regulatory affairs, specifically in German and Swiss markets, and experience working with Swissmedic and BfArM.Key responsibilities include providing strategic guidance on regulatory requirements and submissions, supporting national...

  • International Regulatory Affairs Specialist

    vor 3 Wochen

    Berlin, Berlin, Deutschland Berlin-Chemie AG Vollzeit

    Join Our Team as a Regulatory Affairs ExpertBerlin-Chemie AG, a leading pharmaceutical company, is seeking a highly skilled Regulatory Affairs Manager to join our team in Berlin. As a key member of our International Regulatory Affairs & Drug Safety Department, you will be responsible for the acquisition and regulatory management of international marketing...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Berlin, Berlin, Deutschland GULP – experts united Vollzeit

    Regulatory Affairs ManagerGULP – experts united is seeking a highly skilled Regulatory Affairs Manager to join our team in Berlin. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements for our medical technology products.Key Responsibilities:Develop and maintain documentation for regulatory approvals in...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Berlin, Berlin, Deutschland GULP – experts united Vollzeit

    Regulatory Affairs ManagerGULP – experts united is seeking a highly skilled Regulatory Affairs Manager to join our team in Berlin. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements for our medical technology products.Key Responsibilities:Develop and maintain documentation for regulatory approvals in...

  • Regulatory Affairs Specialist

    vor 2 Wochen

    Berlin, Berlin, Deutschland S-Communication Services GmbH Vollzeit

    JobbeschreibungWir suchen einen erfahrenen Regulatory Affairs Specialist, der unsere Unternehmen bei der Koordination und Organisation von Projekten im regulatorischen Umfeld unterstützt.VerantwortlichkeitenKoordination und Organisation von Projekten im regulatorischen UmfeldUnterstützung bei der Durchführung von ProjektenÜberwachung der Umsetzung von...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Berlin, Berlin, Deutschland GULP – experts united Vollzeit

    Regulatory Affairs ManagerGULP – experts united is seeking a highly skilled Regulatory Affairs Manager to join our team in Berlin. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements for our medical technology products.Key Responsibilities:Develop and maintain documentation for regulatory approvals in...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Berlin, Berlin, Deutschland GULP – experts united Vollzeit

    Regulatory Affairs ManagerGULP – experts united is seeking a highly skilled Regulatory Affairs Manager to join our team in Berlin. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements for our medical technology products.Key Responsibilities:Develop and maintain documentation for regulatory approvals in...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Berlin, Berlin, Deutschland Parexel Vollzeit

    About the Role:We are seeking a highly skilled Regulatory Affairs Consultant to join our team at Parexel. As a key member of our regulatory team, you will provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland.Key Responsibilities:Provide expert advice on new product applications and lifecycle maintenanceSupport...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Berlin, Berlin, Deutschland Parexel Vollzeit

    Unlock Your Potential in Regulatory AffairsWe are seeking a highly skilled Regulatory Affairs Consultant to join our dynamic team at Parexel. As a key member of our team, you will provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland.Key Responsibilities:Develop and implement regulatory strategies to ensure...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Berlin, Berlin, Deutschland Parexel Vollzeit

    Unlock Your Potential in Regulatory AffairsWe are seeking a highly skilled Regulatory Affairs Consultant to join our dynamic team at Parexel. As a key member of our team, you will provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland.Key Responsibilities:Develop and implement regulatory strategies to ensure...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Berlin, Berlin, Deutschland Parexel Vollzeit

    Unlock Your Potential in Regulatory AffairsWe are seeking a highly skilled Regulatory Affairs Consultant to join our dynamic team at Parexel. As a key member of our team, you will provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland.Key Responsibilities:Develop and implement regulatory strategies to ensure...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Berlin, Berlin, Deutschland Parexel Vollzeit

    Unlock Your Potential in Regulatory AffairsWe are seeking a highly skilled Regulatory Affairs Consultant to join our dynamic team at Parexel. As a key member of our team, you will provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland.Key Responsibilities:Develop and implement regulatory strategies to ensure...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Berlin, Berlin, Deutschland Olympus Vollzeit

    Job Title: Regulatory Affairs ManagerAs a key member of the Olympus team, the Regulatory Affairs Manager plays a vital role in ensuring the company's products comply with international regulations. This includes providing regulatory guidance, supporting product launch compliance, and maintaining expertise in evolving industry standards.Key...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Berlin, Berlin, Deutschland GULP – experts united Vollzeit

    Regulatory Affairs ManagerGULP – experts united is seeking a highly skilled Regulatory Affairs Manager to join our team in Berlin. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements for our medical technology products.Key Responsibilities:Develop and maintain documentation for regulatory approvals in...

  • Regulatory Affairs Specialist

    vor 4 Wochen

    Berlin, Berlin, Deutschland GULP – experts united Vollzeit

    Regulatory Affairs ManagerGULP – experts united is seeking a highly skilled Regulatory Affairs Manager to join our team in Berlin. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements for our medical technology products.Key Responsibilities:Develop and maintain documentation for regulatory approvals in...

  • Regulatory Affairs Specialist

    vor 2 Wochen

    Berlin, Berlin, Deutschland S-Communication Services GmbH Vollzeit

    Wir suchen einen erfahrenen Regulatory Affairs Specialist, der unsere Unternehmen bei der Umsetzung regulatorischer Anforderungen unterstützt.Deine Aufgaben:Regulatorische Anforderungen identifizieren und umsetzenKooperation mit Fachteams und operativen EinheitenRegulatorische Aufgaben für einzelne IT-Tools übernehmenÜberwachung der Umsetzung im...

  • Regulatory Affairs Specialist

    vor 3 Wochen

    Berlin, Berlin, Deutschland STRAGO Vollzeit

    Job Overview:We are seeking a detail-oriented and proactive Regulatory Affairs Associate to support the preparation and submission of regulatory documents required for the approval and maintenance of products in various markets. In this role, you will work closely with cross-functional teams, ensuring that regulatory submissions comply with local and...

  • Regulatory Affairs Specialist

    vor 2 Wochen

    Berlin, Berlin, Deutschland GULP – experts united Vollzeit

    We are seeking a Regulatory Affairs Manager to join our team at GULP – experts united. The ideal candidate will have experience in the field of regulatory affairs and be able to create and maintain documentation for the approval of pharmaceutical products in German and English.Key Responsibilities:Creation and maintenance of documentation for the approval...