About the role#
Enable Injections is looking for a Regulatory Affairs Co-op to join our team in Cincinnati. You will support our regulatory processes by maintaining documentation, assisting with submissions, and ensuring our labeling meets specific requirements. This role is full-time and requires you to work on-site.
What you'll do#
- Conduct literature-based research and draft responses to customer information requests.
- Help prepare technical files, master files, and other regulatory submissions.
- Support the documentation needed for investigational clinical studies.
- Track labeling, change controls, licenses, and registrations.
- Write or verify specifications and maintain product and process documentation.
- Identify areas for improvement and suggest solutions to problems.
What you'll need#
- You are currently pursuing a bachelor’s degree in biology, chemistry, computer engineering, electrical engineering, mechanical engineering, or a related field.
- A solid understanding of Quality Systems Regulations.
- Strong organizational and time management skills.
- You can follow defined procedures and work independently or as part of a team.
- Good written and verbal communication skills.
- You are able to interpret basic data and assess problems with guidance.
Location & details#
- This position is based on-site in Cincinnati, Ohio.
- This is a paid, full-time role.
- You must be able to remain in a stationary position for extended periods and operate standard office equipment.
About Enable Injections, Inc.
Enable Injections is a medical equipment manufacturer based in Cincinnati, Ohio. Founded in 2010, the company develops wearable drug delivery systems. Its primary product is the enFuse device, which delivers large volumes of therapeutics through subcutaneous administration. The company employs 223 people.
How to get in at Enable Injections, Inc.
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