Medical Device/ Drug Compliance (Senior) Expert (m/f/d)
Under the responsibility of the Lead Medical Device /Drug Compliance, Quality and Risk in the Design Control and Product Center “Concentrates and Disinfectants” department a new position is proposed:
Medical Device Compliance (Senior) Expert (m/f/d) you will be responsible for maintaining product compliance and preparing as well as coordinating product compliance in accordance with the relevant regulations.
Your task:
- Preparation and maintenance of the Technical Documentation/Regulatory documentation
- Management of technical documentation and STED requests
- 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 Sustaining Center projects from regulatory perspective, execution of change tasks
- Preparation of Instructions for use and labeling materials
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 §820.250, etc.)
- Knowledge of sterilization processes, clean room requirements and of validation methods are advantageous
- IT user skills in MS Office (QTARK or PDM systems are an advantage)
- Fluent in English and German (written and spoken)
Our offer for you:
There is a lot you can discover at Fresenius Medical Care, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you have - for your professional future with meaning:
- The opportunity to work remotely
- Whether in front of or behind the scenes - you will help to make better medicine accessible 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 solution together, not the quickest one
- 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
Career with a purpose
Inclusion and diversity
Stability
Learning and development
Local benefits
Work-life balance
At a glance
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We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
What we stand for
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.
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