We are looking for a Medtech Manager to join our team.


Location : Italy, Spain, Greece or Portugal

Business travel to be planned with clients.

Group 10

The Medtech Manager will support the team on :

  • Quality & Regulatory Technical Expertise
  • Carrying out also activities as project management , reporting and team coordination

Group 11

  • Technical Background ( Engineering, Physics, Chemistry, Pharma)

Group 12

  • At minimum 4-5 years

Group 13

  • English (mandatory)/Italian, nice to have French
  • Operational activity:

    Quality and Compliance:

    ISO 13485 QMS in Medical Devices, 21 CFR PART 820



    Medical Device Regulation 2017/745

    Knowledge of Technical Documentation for Medical Devices

    Able to write and review technical documentation for class II & III medical devices

    Knowledge of MDR harmonized standard, especially for:

    -ISO 14971 and ISO/TR 24971 Risk management approach and tools for medical devices

    – SaMD (Software as Medical Device) in the framework of EN

    62304 an 82304-1 (preferred)

    -Usability according to ISO 62366-1

    Experience with active devices

    Local Registration (in EU countries) of Medical Devices

    FDA submission pathways, including 510k (mandatory), PMA/De Novo/Breakthrough (nice to have)


    Project coordination/management:

    Project team lead support, coordinating different projects on RA and Quality and Compliance Activities

    From Kick-off to follow the complete pathway of delivery, including handling milestones, challenges and reporting


    The resource will be also in charge to get on track periodic reporting of invoicing together with CSE team.


    Team coordination:

    Support team members on handling projects with periodic session to track project activity and interact with clients on specific technical aspects to support the team.

  • Additional skills 

Handling Technical documentation in Medical Devices

Able to support the transition from MDD to MDR

Able to conduct audit

Able to deal with Notified Bodies and Competent Authorities (e.g. FDA)

064 - Medtech Manager