In your role as (Senior) Material Compliance Expert (m/f/d) you will be responsible for material compliance evaluation of medical devices according to the Regulation (EU) 2017/745 (MDR) and other regulatory guidelines/requirements and to ensure documentation of EHS compliance of FME’s product portfolio.

Your tasks

Evaluation of raw materials as well as finished products concerning regulatory EHS-requirements on substances and materialsContact person to external suppliers concerning the before mentioned requirementsCollaborate with engineering teams from the early stages of development to provide material compliance input and supportSupport in second source and material change projectsSupport regulatory affairs and value stream interfaces with required information regarding material compliance, e.g. tender requestsSupports creation and maintenance of dossiers for Nordic eco labeling (Nordic Swan)Providing summaries of expert advice (e.g. author of expert statements)Acting as sponsor in Material Safety Data Sheet generationExpert within cross functional teams concerning EHS material compliance questions

Your profile

Successfully completed scientific background (master’s degree) in chemistry, material science, biology, or related fieldsAdvanced knowledge of material compliance / EHS related regulations and standards (REACH, POP, MDR, RoHS, CLP, Packaging etc.) First years of experience in regulatory affairs or quality environment in pharmaceutical/medical device fieldKnowledge of applicable Quality Management standards (e. g. ISO 13485, ISO 14971, ICH Q10, EU GMP, FDA 21 CFR §820.1, etc.)Knowledge of internal and external processes and structures, and of the (global) corporate quality management requirementsKnowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 2017/745, MDSAP etc.)Knowledge of medical device risk management and related regulationsGood and professional relationship to and communication with international colleagues and superiorsHigh engagement on achieving the targets and on the objectives of the position, proactive and solution-oriented approach towards problems, ability to work independently as well as within the cross-functional teamFluent in English, in written and spoken, and a good knowledge of German