Co-op, Regulatory Affairs (Cincinnati, OH, US, 45241)

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

Location: Onsite

Status Type: Full Time

QUALIFICATIONS

Required

• Pursuing a bachelor’s degree in science, engineering, or a related field

Skills & Competencies

• 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

Physical Requirements

• Must be able to remain in a stationary position for extended periods of time
• Ability to constantly operate a computer and other office equipment, such as printer, telephone, etc.
• Ability to move about inside the office to access file cabinets, office machinery, etc.
• Position requires being physically present on the premises during regular company hours or as approved by management

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