Regulatory/Quality Systems Specialist
Office-based Minneapolis, MN
Regulatory/Quality Systems 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.
- 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.
- Contributes to the development and implementation of product development, manufacturing and strategic operating.
- Establishes project timelines/schedules.
- Other duties as assigned.
Bachelor's degree plus one or more years applicable experience with medical devices, regulatory agency, or advanced degree with more than 1-year experience.
- Ability to comprehend the engineering principles, clinical, and physiological aspects of medical
- Effective oral and written communication
- Effective interpersonal
- Strong organizational skills and detail-orientation.
- Demonstrated abilities to communicate cross-functionally throughout
- Familiarity with basic computer applications, e.g., Word,
- Writing skills: ability to comprehend and assess information from multiple sources, then create formal summaries and conclusions of that information for submission to regulatory agencies
- FDA or EU compliance experience
- Project management experience
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