Regulatory/Quality System Specialist

Job Overview:

We are hiring a Regulatory/Quality System Specialist to join our team in Minneapolis, MN office.

The Regulatory/Quality System Specialist will provide assistance to clients in the implementation of regulatory strategies to ensure timely global commercialization of new and enhanced devices, in compliance with applicable regulations and standards (US and international). Ensures compliance with applicable national and international regulations and standards during all phases of the product life cycle. Assists in the implementation of systems for the preparation of quality submissions, which meet regulatory requirements to ensure timely device approval and maximize market opportunities. Assists in regulatory inspections, field corrective actions, post market surveillance, patient registration, device tracking, complaint reporting and MDR and vigilance reporting activities. Contributes to the development and implementation of product development, manufacturing and strategic operating plans. Establishes project timelines/schedules. Other duties as assigned. Education/Qualifications:

Bachelor’s degree plus one or more years applicable experience with medical devices, regulatory agency, or advanced degree with more than 1-year experience.  This position is office-based in Minneapolis, MN. Experience:Knowledge of FDA regulations and one or more years device submission experience. FDA or EU compliance experience preferred. Project management experience preferred. Ability to comprehend the engineering principles, clinical, and physiological aspects of medical devices. Effective oral and written communication skills. Effective interpersonal skills. Strong organizational skills and detail-orientation. Demonstrated abilities to communicate cross-functionally throughout organizations. Familiarity with basic computer applications, e.g., Word, PowerPoint.