Medical Device Compliance Expert Dialyzers and - Sankt Wendel, Deutschland - Fresenius Medical Care

Fresenius Medical Care

Geprüftes Unternehmen

Sankt Wendel, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

In your role as Medical Device Compliance (Senior) Expert (M/F/d) you will be responsible for maintaining product compliance and preparing as well as coordinating product documentation in accordance with the relevant regulations in the Design Control & Product Center Dialyzers & Filters.

Your assignments:

Preparation and maintenance of the Technical Documentation/Regulatory documentation
Management of technical documentation and STED requests from registration units
Perform Regulatory activities to maintain/receive product compliance e. g. implementing (new) laws/regulations and changes
Creation and preparation of declaration of conformity
Support Regulatory Affairs and Value Streams projects from regulatory perspective, execution of change tasks
Preparation of Instructions for Use
Support and interface to Risk Manager
Supporting function in case of Notified Bodies / Authorities audits for RA documentation review

Your profile:

University degree with an engineering, scientific or technical background
Experience in Regulatory Affairs in a pharmaceutical or medical environment
Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 2017/745, MDSAP etc.)
Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR , etc.)
Knowledge of sterilization processes, clean room requirements and of validation methods are advantageous
IT user skills in MS Office (TrackWise Workflow or Windchill PDM systems are an advantage)
Fluent in English (written and spoken)

Our offer to you:

There is a lot for you to discover at Fresenius, because we have a lot to offer.

No matter in which field you are an expert (M/F/d) and how much experience you bring with you - for your professional future with meaning:

The opportunity to work on a mobile basis, individually in consultation with your manager
Whether in front of or behind the scenes you will help to make better and better medicine available to more and more people around the world
Individual opportunities for selfdetermined career planning and professional development
A corporate culture in which there is enough room for innovative thinking to find the best, not the fastest, solution together
A large number of committed people with a wide range of skills, talents and experience
The benefits of a successful global corporation with the collegial culture of a mediumsized company