Regulatory Engineer- Medical Devices
Pubblicato il 01-08-2026 - Linkedin in Italia
We are seeking a motivated CSV Engineer to join our team. The ideal candidate will be responsible for ensuring that computerized systems are validated in compliance with industry regulations (GxP, FDA 21 CFR Part 11, EU Annex 11) and internal company procedures.
Responsibilities
~ :Develop, review, and execute validation documentation (URS, FS, DS, IQ, OQ, PQ, traceability matrices, validation reports, etc.
~)Ensure systems’ compliance with applicable regulatory requirement
~ sParticipate in risk assessments and define validation strategie
~ sProvide expertise and support during internal and external audit
~ sLiaise with Quality, IT, and business teams to coordinate validation activitie
~ sMonitor and maintain validated state of computer systems over their life cycl
~ eTrain end-users on relevant procedures and systems,
if require
d
Qualification
~ s:Bachelor’s or Master’s degree in Life Sciences, Engineering, Computer Science, or related fie
~ ldPrior experience in computer system validation, preferably in regulated industries (pharma/biotech/medical device
~ s)Strong understanding of GxP guidelines and relevant regulations (e.g., 21 CFR Part 11, Annex 1
~1)Experience with validation of laboratory, manufacturing, or quality syste
~ msExcellent documentation, organizational, and communication skil
~ lsAbility to work on multiple projects simultaneously and as part of a te
~ amFluency in Engli
sh