Wearable Sensing is a growing San-Diego based company focused on the development of applications of dry electrode EEG sensor technology. Their first products are wearable mobile EEG headsets that are renowned for their signal quality and usability. These comfortable headsets are opening the door to innovative applications in commercial and medical domains. Their office environment is friendly and relaxed, but that is thanks to their team’s highly self-motivated and perfectionist work ethic.

The intern will be involved in all aspects of filing an 510(k) application to the FDA for Wearable Sensing’s first medical product, an ambulatory EEG headset. The intern will assist in all aspects of the submission, from document control, to finalizing documents describing procedures and biocompatibility results, to discussions with the FDA. This is an excellent opportunity for a recent graduate to test and demonstrate their new skills and training in regulatory affairs. As a team member, the new intern would be expected to assist in assembling the 510(k) application package through final submission to the FDA, including:

• Assisting in completion of suitable document control and Quality System
• Interfacing with engineers to document manufacturing procedures
• Interface with 3rd parties providing biocompatibility testing
• Participation in design reviews and interfacing with the FDA
• Preparation of 510(k) pre-submission and application packages

Skills and requirements: The successful candidate will have strengths in following areas:

• Clear understanding of regulatory affairs workings and methodologies
• Ability to communicate with engineers and medical professionals
• Demonstrated fluency in English writing, grasp of pertinent terminology and understanding of proper document preparation requirements.
• Responsible, self-driven individual who is meticulous and dedicated to professional excellence, and motivated to seek new creative solutions to cutting-edge projects
• Flexible team-player with good communication skills who is capable of independent work with a sense of urgency to resolve issues and complete project goals on time
• Ambitious worker who seeks excellence in workmanship, strives for professional growth through continued learning opportunities and hands-on experiences.

Compensation is commensurate with experience. If you feel your skills match our requirements, please email your resume, copy of transcripts, and a paragraph stating interest and availability to [email protected]. Be sure to indicate current status i.e. graduate student, undergraduate level, and actual or expected graduation date.

Job Location Information: Wearable Sensing 16744 West Bernardo Drive San Diego, CA 92127