CRQE Specialist Frestedt Incorporated - Saint Louis Park, MN Purpose To assist with Clinical, Regulatory, Quality and Engineering (CRQE) projects for pre-and post-market products and to complete specific projects while ensuring consistency with regulations, quality standards, commitments and goals. Essential Functions and Responsibilities * Project management including planning, implementation, prioritization, meetings minutes and data entry/analysis on behalf of clients to keep projects on time, high quality and within budgets * Develop and execute on project requirements which may include: * clinical research studies/clinical evaluation reports (CER) * regulatory submissions * quality management systems * engineering reports * Ensuring quality by following internal and external SOPs, Work Instructions and Forms/Templates for successful preparation of robust, high quality deliverables * Read, analyze and implement regulations, standards and guidance documents (e.g. FDA, EU) relevant to client projects across multiple industries and disciplines * Develop materials for on-line and in-person training (e.g. PowerPoint presentations) * Conduct literature searches and communicate scientific content in a clear, concise manner * Other duties as assigned Qualifications: * Masters Degree or PhD in a medical or science-related field or equivalent work experience * At least 3 years clinical, regulatory, quality and/or engineering work experience * Experience and qualification in project management * Advanced computer skills with Outlook, Word, Excel, PowerPoint and other software tools * Able to productively interact with Frestedt Inc. staff and client companies including corporate executives, research sites and research subjects Requirements: * Must be focused, efficient, detail oriented and able to work independently * Able to travel to client sites as needed (approximately 10% travel) * Demonstrated ability to execute projects on time and on budget * Must have excellent critical thinking and problem-solving skills * Able to coordinate training sessions and to secure the required training documentation * Able to reprioritize immediately as new projects arrive * Passion for clinical research, regulatory, quality and engineering affairs activities for pharmaceutical, medical device and food industries Job Type: Full-time 7 hours ago - save job Apply Now Please review all application instructions before applying to Frestedt Incorporated.