Co-op, Regulatory Affairs - Fall 2026

Enable Injections Inc. • Sharonville, OH

1d • Onsite

About The Position

This is a full-time co-op position for Fall 2026, located onsite. The role involves assisting with various regulatory affairs tasks, including research, documentation preparation, and tracking of regulatory items. The position requires strong organizational and communication skills, a good understanding of Quality Systems Regulations, and the ability to work both independently and as part of a team.

Requirements

• Pursuing a bachelor’s degree in science, engineering, or a related field
• Ability to participate as a team member
• Ability to work independently
• Good interpersonal and organizational skills
• Good written and verbal communication skills
• Strong understanding of Quality Systems Regulations
• Good time management skills
• Ability to follow defined procedures
• Ability to collaborate and maintain cooperative work relationships with others
• Ability to adapt to change and handle unexpected situations with close guidance
• Ability to stay focused on tasks, organize, compare, interpret basic data, and assess problems with guidance

Responsibilities

• Assist with literature-based research and assist with responses to customer requests for information
• Assist in the preparation of master files, technical files, or other regulatory submissions
• Assist in the preparation of documentation needed to support investigational clinical studies
• Assist with country-specific labeling requirements
• Assist in tracking labeling, change controls, licenses, and registrations
• Identify areas for improvement, problem-solve, and suggest solutions
• Complete simple or basic tasks to include any of the following: writing and/or verifying specifications, maintaining product/process documentation

What This Job Offers

• Job Type: Full-time
• Career Level: Intern