Position Summary: The Regulatory Affairs Intern supports the Regulatory Affairs team by performing various regulatory activities related to the design, development, testing, manufacturing, and market authorization of SMD medical devices, including hardware imaging equipment and AI-based software. Spectral MD's Regulatory Affairs team ensures products comply with applicable regulations and standards. Essential Duties and Responsibilities: Assist with the development of regulatory submission templates. Ensure all new submission documents are filed and updated regularly in the Technical File for each product as appropriate. Maintain and update the technical file documentation for commercial products. Track Engineering Change Order action items, closeout, and filing. Assisted with the revision of documents and records related to regulatory affairs. Assist with developing and maintaining a regulatory submission tracking system for all commercial products. Assist with developing and maintaining a SharePoint web workspace for the department. Assist in other regulatory responsibilities requested by the Regulatory Affairs Director. Qualifications: Required education and/or experience: Currently pursuing a bachelor's degree in science or engineering Knowledge, Skills, and Abilities: Experience working in cross-functional organizations. Excellent computer skills, including Microsoft Office Suite of products (Word, PowerPoint, Excel, SharePoint, Teams, etc.) and Adobe Acrobat. Strong communication and interpersonal skills. Additional Qualifications (preferred) Familiarity with the following Regulations/Standards: 21 CFR 820
...Benefits options available (medical, dental, vision, 401k) Access to a supportive ProCare Therapy team throughout your assignment Apply Today! If you are a skilled ASL interpreter with a passion for working with students in a school setting, contact: Joshua...
Join Our Green Energy Team as an Appointment Setter!Hello and welcome! At G-Energy, we are looking for friendly and motivated Appointment Setters to join our growing team! If you love talking to people and making connections, this role is perfect for you. Your main mission...
...flexibility and responsiveness. Our Core Values include integrity, trust and loyalty. RT&T, a joint venture of InDyne, Inc. and Amentum Services, Inc. is the prime contractor to support the Atlantic Range Technical Support Services (ARTSS) for the Naval Air Warfare Center...
...responding to building fire alarm and electronic security systems, closed circuit television,... ...United States.Have not had a previous private investigator or security guard license revoked... ...up until they have locked out their arms. The test is measured in 5-pound increments...
Job Overview: Ready to launch a new career in sales? Looking to bring your experience to a high-growth team? Or maybe you're seeking a flexible, part-time role with serious earning potential? This position is built for all of the above.At Marvin,your performance drives ...