**Position in Ogden, Utah.** **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + Ensure that all design control deliverables comply with applicable regulatory requirements and design controls SOPs + Prepare together with Project Manager’s the design and development documentation for project and for design control activities. + Support Product Center/Project Manager to get part needed to Medical Device Compliance and Regulatory Affairs to complete Technical Dossier/Registration dossier. + Provide Training on design & development relevant quality requirements. + Provide input to design and development and design changes and take accountability for quality compliance as a member of the cross-functional project team representing Product Center for Design Quality part. + Review and approve all product development and Design Change projects in compliance with Fresenius Quality Management System / SOP requirements by: + Preparation / Review and approval of applicable design control documentation + Design Review, Phase Exit Review and Milestone approval + Preparation of applicable document and sample review of design control documentation during project execution + Act as Quality Approver for Design and Development related NC/CAPA + Create and monitor compliance metrics of design controls in development and change management activities. + Audit support of design and development sessions + Providing management quality review inputs for Design and development + Support Product Center in writing MDR Technical Documentation and related documentation. **EXPERIENCE AND REQUIRED SKILLS:** + Degree in Technical/Engineering and/or Scientific background, in lieu of degree additional years of relevant experience and/or education may be considered. + Minimum 2 years in Regulatory Affairs or similar in pharmaceutical/medical field + Strong relationship building with international colleagues and superiors. + High engagement on achieving the targets and 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 + Independent working structure + Autonomy in decision making. + Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 745/2017, MDSAP etc.) + Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CFR, etc.) + Knowledge of internal and external processes and structures and of the corporate Quality Management requirements + Knowledge of CAPA methodology + Knowledge in statistical methods + Support Regulatory Affairs + Capability to relate to all corporate functions (at corporate level) + Interface to keep up to date the technical documentation relevant for regulatory purposes (e.g. usability report, interface verification test report, biocompatibility, labelling etc.)