Regulatory Affairs Intern
CooperCompanies · Trumbull, Connecticut, US
The Summer Intern program provides college students with the opportunity to participate in meaningful projects that contribute to the overall business unit o...
Job description
The Summer Intern program provides college students with the opportunity to participate in meaningful projects that contribute to the overall business unit objectives. In addition to the assigned projects, Interns are given the opportunity to participate in activities that encourage networking with peers, managers, and employees. The Regulatory Affairs Intern will support the preparation, organization, and maintenance of regulatory documentation needed for medical device submissions and compliance activities. This role helps ensure products meet FDA and international regulatory requirements through hands ‑ on involvement with daily RA tasks. Essential Functions & Accountabilities: - Support data integrity projects for new Regulatory Information Management (RIM) and Product Lifecycle Management systems implementation - Handles data entry, data cleaning, and any RA hold investigations - Support collaboration project to improve regulatory data management Qualifications, Knowledge, Skills and Abilities: - Strong attention to detail and ability to manage multiple tasks. - Basic understanding of FDA or global medical device regulations (preferred, not required). - Proficient in Microsoft...