064 - Medtech Manager

3 settimane fa

Milano, Italia Groupe Productlife A tempo pieno

We are looking for a Medtech Manager to join our team.
Location : Italy, Spain, Greece or Portugal Business travel to be planned with clients. ResponsibilitiesThe Medtech Manager will support the team on :
Quality & Regulatory Technical ExpertiseCarrying out also activities as project management , reporting and team coordinationEducationTechnical Background ( Engineering, Physics, Chemistry, Pharma)ExperienceAt minimum 4-5 yearsSkillsEnglish (mandatory)/Italian, nice to have FrenchOperational activity:Quality and Compliance: ISO 13485 QMS in Medical Devices, 21 CFR PART 820
Regulatory: 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)
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