Expert Material Compliance, Biocompatibility and Toxicology Evaluations - Bad Homburg, Deutschland - Fresenius Medical Care, Global Manufacturing, Quality & Supply

Beschreibung

Main tasks:

Material compliance:

Evaluation of raw materials as well as finished products concerning regulatory EHS-requirements on substances and materials (REACH, POP, MDR, CLP, Packaging Directive etc.)

Contact person to external supplier concerning the before mentioned requirements

Creation and maintenance of dossiers for Nordic eco labeling (Nordic Swan)

Support Registration/Regulatory Affairs and Product Center with required information regarding material compliance, e.g. Tender requests

Value Stream and Development support activities:

Expert within cross functional teams concerning EHS material compliance and biocompatibility questions

Support in second source and material change projects

Biocompatibility/Toxicology:

Support Development of biocompatibility evaluation strategies

Performance of safety and risk assessments for medical devices, based on the used raw materials, on extractable and leachable chemicals or on biocompatibility studies (ISO

Biocompatibility Evaluations and Toxicological Expert statements

Providing expert advice (e.g. expert statements)

Acting as sponsor, study monitor and contact for chemical/biocompatibility studies in internal and external laboratories (creation of test plans and test reports)

Compilation of overall biological safety assessment according to ISO

Secondary Tasks:

Support regulatory compliance, speed to market, reduction of risks to patients resulting in an increase in overall user satisfaction and enhanced regulatory compliance (as member of CFT or extended sub-teams).

Support a Design Control approach and provide expertise to Value Streams and Q&R for compliance with applicable regulations (EU directive, local countries regulations).

Close Collaboration regional as well as plant EHS departments and the central biocompatibility group

Support Sustainability activities and internal and external audits

Your Profile:

Scientific background (Masters degree) in Toxicology, Chemistry, Biology or Material Sciences or related fields

Strong background in chemistry of medical polymers and materials used in contact with blood and the related analytical methods

Experience of 2-3 years in Regulatory Affairs or Quality environment in pharmaceutical/medical field

High identification with and loyalty to the department and the company

Good and professional relationship to and communication with international colleagues and superiors.

High engagement on achieving the targets and on the objectives of the position, proactive and solution-oriented approach towards problems, ability to work cross functional with all levels of employees

Organizational capacity and analytical ability

Autonomy in decision making

Ability for a cross functional coordination

Advanced knowledge of medical device risk management and related regulations

Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 2017/745, MDSAP etc.)

Advanced knowledge of applicable standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CFR §820.250, etc.)

General knowledge of FDA 510(K) requirements

Knowledge of internal and external processes and structures and of the (global) corporate Quality Management requirements

Knowledge in statistical methods

Experience in scientific writing

English (fluent, very good knowledge)

Required: Office (Excel/Word/Power Point, Outlook, Teams) Knowledge

Additional: SAP, PDM systems as PTC Windchill, FMEA tools

Knowledge of Medical Device field and application, Dialysis and related therapies

Independent working structure, hands on and 'can do' mentality

Attitude to Team Work, ability to work in matrix environment

Global mindset approach

Career with a purposeWe offer an opportunity to create and deliver treatments that save and change lives for the better. We'll support your ongoing development. And you'll be part of a dedicated team of people who inspire each other to create the best possible healthcare outcomes each and every day. Inclusion and diversityJoining Fresenius Medical Care means becoming part of a team that values diversity. We embrace the wealth of different backgrounds, cultures, experiences and opinions that make up our workforce and strive to create an inclusive atmosphere in which all our employees feel valued. StabilityDeveloping innovative products and continuously improving our renal therapies made us the clear market leader in the production of hemodialysis machines, with sustainable, profitable growth . This position provides our employees with the stability and security they need to help improve the lives of our patients. Learning and developmentWe offer participation in programs at world-class business schools, leadership development, regular training for our nurses, health care professionals and manufacturing staff and digital access to high-quality educational content for all employees worldwide 24/7. Local benefitsOur employees enjoy both local and global opportunities for growth and personal fulfilment. We offer local benefits designed to suit the requirements of the respective country and place of work to create ideal conditions everywhere. Work-life balanceWe want to empower people to deliver better care. Therefore, we promote a better work-life balance through flexible working hours, part-time models, the possibility to work from home, and more.