Cendres+Métaux Lux SA

Post

Regulatory Affairs & Clinical Affairs Specialist MedTech / Complaint Manager MedTech (m/f/d) 80 - 100 %

  • 18 September 2026
  • 80 – 100%
  • Post

Job summary

Join a dynamic MedTech company focused on quality and innovation. Enjoy a supportive work environment with flexible hours.

Tasks

  • Lead Complaint Management and coordinate post-market surveillance activities.
  • Evaluate complaints for product safety and regulatory compliance.
  • Manage international product registrations and technical documentation.

Skills

  • Degree in natural sciences, medical technology, or related field.
  • Experience in Regulatory Affairs, Clinical Affairs, or Quality Management.
  • Strong analytical skills and proficiency in German and English.

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About the job

  • Management of complaint handling and coordination of post-market surveillance activities for our MedTech brand products, including complaint processing, trend analyses, and CAPA support
  • Assessment of complaints regarding product safety, reporting obligations, and regulatory impacts
  • Project management and coordination of international product approvals and registrations, as well as support with technical documentation
  • Preparation and updating of clinical and biological evaluations, including literature research and assessment of relevant data
  • Planning and coordination of biocompatibility tests as well as clinical and post-market studies
  • Participation in risk analyses, product changes, and regulatory and normative requirements
  • Review and approval of documents within own area of responsibility, as well as support with training and audits

    • We are looking for a committed and quality-conscious individual to join our team who will responsibly manage regulatory, clinical, and quality-related topics concerning our medical devices. In this versatile role, you will work at the interface between Regulatory Affairs, Clinical Affairs, Quality Management, and our internal departments.

    Regulatory Affairs & Clinical Affairs Specialist MedTech / Complaint Manager MedTech (m/f/d) 80 - 100 %

    Your area of responsibility

    Your profile

    • Completed degree in natural sciences, medical technology, life sciences, or a comparable qualification
    • Professional experience in one or more of the areas of Regulatory Affairs, Clinical Affairs, Quality Management, or Post-Market Surveillance in medical technology
    • Good knowledge of regulatory requirements for medical devices, especially the European Medical Device Regulation (MDR)
    • Experience with technical documentation, clinical evaluations, and/or post-market surveillance
    • Knowledge in complaint management and handling of CAPAs is an advantage
    • Structured, independent, and quality-conscious working style
    • Strong analytical skills and enjoyment of collaboration with different departments
    • Very good German and English skills, both written and spoken; French skills are an advantage

    Our offer

    You can expect an interesting, varied, and responsible role in a modern, future-oriented company. We work with annual working hours and support flexible working time models. You will also be provided with the necessary infrastructure to be able to perform your work remotely as needed.

    Interested in actively shaping the future with us? Send us your complete online application.

    Contact

    Take the next step!

    We look forward to receiving your online application.

    Do you have questions? Julie will be happy to answer them for you.

    Julie Lüthi

    HR Business Partner

    +41 79 798 09 90

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