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 materials
• Contact person to external suppliers concerning the before mentioned requirements
• Collaborate with engineering teams from the early stages of development to provide material compliance input and support
• Support in second source and material change projects
• Support regulatory affairs and value stream interfaces with required information regarding material compliance, e.g. tender requests
• Supports 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 generation
• Expert 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 fields
• Advanced 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 field
• Knowledge 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 requirements
• Knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 2017/745, MDSAP etc.)
• Knowledge of medical device risk management and related regulations
• 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 independently as well as within the cross-functional team
• Fluent in English, in written and spoken, and a good knowledge of German