064 - Medtech Manager

We are looking for a

Medtech Manager

to join our team. Location : Italy, Spain, Greece or Portugal Business travel to be planned with clients. Responsibilities

The Medtech Manager will support the team on : Quality & Regulatory Technical Expertise Carrying out also activities as project management , reporting and team coordination Education

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

At minimum 4-5 years Skills

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