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