Medical Device Compliance

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 cross-location 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 -820.250, 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 self-determined 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 medium-sized company

The position can be filled in Germany or France.