Global Regulatory Affairs Lead

vor 2 Wochen

Lucerne Metropolitan Area, Schweiz GC International AG Vollzeit

Who We Are

GC International AG, based in Lucerne, is a global leader in dental care and oral health. With more than 100 years of history, presence in over 100 countries, and a team of over 3,500 people worldwide, we are proud to support dental professionals with innovative, high-quality products that truly make a difference for patients.

Our teams across Europe, North America, and Asia work together to develop and manufacture precision components for the dental industry, always focused on quality, innovation, and improving lives.

At GC, we believe in working with care and purpose. Our company philosophy,
SEMUI
, is all about thinking from the standpoint of others—whether that's our customers, our teams, or the people who use our products every day. It's this mindset that helps us drive innovation, respect each other, and create real value for the future of oral health.

If you're looking to join a successful, global company with real career opportunities, we'd love to meet you.

About the Role

We are seeking an experienced
Global Regulatory Affairs Lead (m/f/d)
to join our Technology (R&D) team in Lucerne. Reporting directly to the Chief Technology Officer, you will define and execute global regulatory strategies for dental medical devices, ensuring compliance with international standards and enabling timely product registrations across major markets (EMEA, US, APAC, LATAM, EA including Japan). This is a strategic leadership role with global impact.

Key Responsibilities

  • Develop and implement global regulatory strategies for new and existing products.
  • Ensure compliance with ISO standards and international regulations (ISO 13485, ISO 10993, ISO 14971, ISO 14155, EU MDR, FDA).
  • Maintain a centralized regulatory database with 100% accuracy and accessibility.
  • Lead and grow a global regulatory team within a matrix organization.
  • Anticipate regulatory trends and proactively mitigate risks.
  • Collaborate closely with R&D, Quality, Marketing, and Supply Chain teams worldwide.
  • Act as the primary liaison with regulatory authorities and notified bodies (EU, FDA, etc.).
  • Drive continuous improvement in compliance processes and documentation.

Your Profile

  • Master's or higher degree in medical or life sciences, public health, or a related field.
  • 10–15 years of experience in Regulatory Affairs within medical devices (ideally dental).
  • Proven track record in global regulatory strategy and submissions.
  • Strong leadership, communication, and stakeholder management skills.
  • Excellent organizational and time management abilities.
  • Fluent in English; additional languages are a plus.
  • Willingness to travel internationally.

Why Join GC International AG

At GC International AG, you will be part of a growing, innovative company with a global footprint. We offer a collaborative, international work environment where your expertise makes a direct impact.

Ready to Apply?

We look forward to receiving your application. Please note that due to the high volume of applications, only shortlisted candidates will be contacted. Thank you for considering GC International AG as your next career step.

  • EU Regulatory Lead Director

    Vor 2 Tagen

    Zürich Metropolitan Area, Schweiz argenx Vollzeit

    Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to...

  • Regulatory Affairs Manager

    vor 1 Woche

    Sempach, Lucerne, Schweiz B. Braun Group Vollzeit

    Als Schweizer Tochtergesellschaft des weltweit tätigen B. Braun-Konzerns gehören wir zu den Marktführern in der Schweiz und bieten unseren über 1'100 Mitarbeitenden spannende Perspektiven. Wir sind lokal wie auch global eng vernetzt und arbeiten mit Technologien auf höchstem Level.Zur Ergänzung unseres Regulatory Affairs Teams für den Schweizer Markt...

  • Manager, Regulatory, International Markets

    vor 1 Woche

    Lugano Metropolitan Area, Schweiz BridgeBio Vollzeit

    About BridgeBio Pharma, Inc.BridgeBio is a biopharmaceutical company dedicated to discovering, developing, and delivering transformative medicines for patients living with genetic diseases and genetically defined cancers. Since our founding in 2015, we have built a diverse portfolio of more than 20 drug development programs, ranging from early discovery to...

  • Senior Director, Global Launch Lead – empasiprubart in MMN

    Vor 2 Tagen

    Zürich Metropolitan Area, Schweiz argenx Vollzeit

    Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to...

  • Senior Medical Advisor Neurology, Medical Affairs and Evidence Generation

    vor 2 Wochen

    Zürich Metropolitan Area, Schweiz argenx Vollzeit

    Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to...

  • Clinical Operations Development Lead

    vor 16 Stunden

    Zürich Metropolitan Area, Schweiz argenx Vollzeit

    The Clinical Operations Development Lead (CODL) is a key member of the Indication Development Team (IDT), overseeing clinical activities for a specific therapeutic indication (CODL) or across all indications for an asset (early/late phase CODL). The CODL provides operational input and drives strategy for clinical development across the lifecycle of an asset,...

  • GMA Medical Director Pipeline

    vor 16 Stunden

    Zürich Metropolitan Area, Schweiz argenx Vollzeit

    Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to...

  • Global Clinical Program Manager 80

    vor 2 Wochen

    Basel Metropolitan Area, Schweiz ELAN Personal AG Vollzeit

    Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for aGlobal Clinical Program Manager 80%Background:With the combined strength in pharma and diagnostics, the aim to improve health outcomes and...

  • Senior Medical Director Indication Lead

    vor 2 Wochen

    Zürich Metropolitan Area, Schweiz argenx Vollzeit

    Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to...

  • Specialist Quality Assurance

    vor 2 Wochen

    Lucerne Metropolitan Area, Schweiz Gi Group Vollzeit

    For our client, a global pharma company located nearby Lucerne, we are looking for a motivated team player asSpecialist Quality AssuranceOur Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all...