Providing scientific and regulatory support, the full-time Biomedical Engineer Subject Matter Expert will evaluate medical devices, manage regulatory submissions, and coordinate with FDA stakeholders while working remotely. Key responsibilities Perform technical and regulatory reviews of medical devices to assess design, intended use, and performance data Evaluate scientific and engineering information submitted for various regulatory pathways, including 510(k) notifications and De Novo requests Analyze complex engineering issues to support regulatory recommendations and ensure consistent application of standards across teams Required qualifications Bachelor's degree in Engineering, Biomedical Engineering, or a closely related discipline Minimum of seven years of professional experience in engineering, medical devices, or regulatory affairs Demonstrated knowledge of medical device technologies and FDA regulatory frameworks Strong analytical and technical writing skills for clear communication of complex concepts Proficiency in Microsoft Office Suite applications
...Retail Sales Associate - Kohls S/C Part time 4440 13th Avenue SW, Fargo, ND, US 58103 About Old Navy Forget what you know about old-school industry rules. When you work at Old Navy, you're choosing a different path. From day one, we've been on a mission to democratize...
...School Nurse - Substitute (PRN) Time - 7:45am-3:45pm Rate - $300/day (full school day) or $150 (half day) Position Summary: The School Nurse Sub provides compassionate, professional healthcare and first aid to students and staff. This role manages the Health...
...a difference in the lives of patients by fixing equipment that's integral in helping them recover. We are seeking a Biomedical Engineering Specialist to: Diagnose defective medical equipment and implement repairs without direct supervision in both shop...
...deadlines in a remote environment.Key responsibilitiesSync audio vocals with video mouth movements and perform all aspects of audio recording, editing, and mixingEdit and clean raw audio files, removing noise and inconsistencies while collaborating with the production...
Overview: Speech Therapist-ccc Full time | Mobile Outpatient Therapy Westfield MA... ...program. Responsibilities: The Speech Language Pathologist will primarily provide... ...caregivers, implements the speech language pathology treatment plan, and completes all related...