Medical Device Compliance - Schweinfurt, Deutschland - Fresenius Medical Care

Fresenius Medical Care
Fresenius Medical Care
Geprüftes Unternehmen
Schweinfurt, Deutschland

vor 2 Wochen

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung

In your role as Medical Device Compliance & Quality and Risk Group Lead (M/F/d) you will be the technical group leader of Compliance, Regulatory, Risk and Design Quality Experts for Disinfectants for Hemodialysis machines and water treatment systems.


Your assignments:


  • Preparation and coordination of product and production related basic regulatory documentation for product compliance according to all relevant regulations
  • Forster and support crosslocation activities to monitor product quality preparation and maintenance of the Technical Documentation/Regulatory documentation
  • Preparation and maintenance of the Technical Documentation/Regulatory documentation
  • Management of technical documentation and STED requests from third parties or from other FME departments
  • Interface with R&D and other functions to keep up to date the technical documentation relevant for regulatory purposes (e.g. usability report, interface verification test report etc.)
  • Perform Regulatory activities to maintain/receive product compliance e. g. implementing (new) laws/regulations and changes
  • Ensure the quality of design control activities and correctly realizing product development processes
  • Creation and preparation of declaration of conformity
  • Support for Clinical Evaluation Reports, creation of technical part
  • Support Regulatory Affairs for product related statements and confirmations

Your profile:


  • University degree with an engineering, scientific or technical background
  • Several years of experience in Regulatory Affairs in pharmaceutical or medical field
  • Knowledge of applicable quality management and of risk management standards (e.g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR , etc.)
  • Experienced in medical device regulations (MDD 93/42/EEC, MDR 2017/745, etc.)
  • Familiar with internal and external processes & structures and the corporate Quality Management requirements
  • Knowledge of sterilization processes, clean room requirements and of validation methods are advantageous
  • Experience in project management
  • IT user skills in MS Office (TrackWise Workflow and 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
The position can be filled in Germany or France.
Mehr Jobs von Fresenius Medical Care
Alle Jobs von Fresenius Medical Care anzeigen