Senior) Regulatory Affairs Specialist (m/f)

REFERENZNUMMER:

364386/10

IHRE AUFGABEN:

-Organize & perform the creation of the 2017/745 EU MDR annex II technical documentation (Class I – Class III) for the navigation portfolio & pipeline
-Organize & perform the creation of the 2017/745 EU MDR Annex I GSPR checklist for the navigation portfolio & pipeline
-Help the cross-functional EU MDR project team with identifying potential gaps and define strategies for effective gap closures in the area of technical documentation and GSPR
-Drive improvements & efficiency of the annex II technical documentation creation in an electronic document management system
-Support updates of necessary SOPs and templates under EU MDR for the area of Regulatory Affairs and adjacent departments
-Support of the initial EU MDR notified body audit and technical documentation sampling, where applicable
-Help with regular Technical File maintenance under 93/42 EEC and change management activities, where applicable

IHRE QUALIFIKATIONEN:

-Profound experience in a Regulatory or Quality role for a medical device manufacturer or as consultant
-Degree in Life Sciences, Engineering or equivalent
-Ideally familiar with electronic medical devices & software
-Profound knowledge of 93/42 EEC and technical files/design dossiers
-Basic 2017/745 EU MDR knowledge
-Enjoys working in a regulated environment (FDA, ISO 13485)
-Hands-on mentality
-Excellent writing skills (English and German), fluency in English

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager