Regulatory Affairs Co-op: Submissions & Compliance

Cintrifuse; Cincinnati (OH); On-site; USD 40,000 - 48,000; Full time

Job summary

Cintrifuse is seeking a student to support regulatory activities onsite in Cincinnati. This role involves literature research, preparing documentation for regulatory submissions, and assisting with country-specific labeling requirements under close supervision.

The candidate will gain exposure to Quality Systems Regulations and documentation processes while developing strong teamwork and communication skills in a professional setting.

Qualifications

• Pursuing a bachelor’s degree in science, engineering, or a related field.
• Familiarity with regulatory-style documents is a plus.
• Strong attention to detail and documentation practices.

Responsibilities

• Assist with literature-based research and responses to customer information requests.
• Assist in preparing master files, technical files, or regulatory submissions.
• Assist in preparing documentation to support investigational clinical studies.
• Assist with country-specific labeling requirements.
• Assist in tracking labeling, change controls, licenses, and registrations.
• Identify areas for improvement and propose solutions.
• Complete basic tasks such as writing/verifying specifications and maintaining documentation.

Skills

Team player

Independent worker

Interpersonal skills

Written and verbal communication

Quality Systems Regulations

Time management

Procedures adherence

Cooperative work relationships

Adaptability with guidance

Data interpretation

Education

Pursuing bachelor’s degree in science/engineering

Job description

Cintrifuse is seeking a student to support regulatory activities onsite in Cincinnati. This role involves literature research, preparing documentation for regulatory submissions, and assisting with country-specific labeling requirements under close supervision.

The candidate will gain exposure to Quality Systems Regulations and documentation processes while developing strong teamwork and communication skills in a professional setting.