Co-op, Regulatory Affairs

Parkview Medical Center, Inc.; Cincinnati (OH); On-site; USD 45,000 - 65,000; Full time

Job summary

Parkview Medical Center, Inc. in Cincinnati, Ohio seeks a detail-oriented team member to support literature-based research and assist with regulatory submissions. This role emphasizes accuracy, adherence to procedures, and collaboration with regulatory teams.

The position involves preparing master/technical files and documentation for investigational studies, and tracking licenses, registrations, and labeling requirements while maintaining strong communication with stakeholders.

Qualifications

• 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.
• 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

Education

Bachelor's degree in science, engineering, or related field

Job description

Select how often (in days) to receive an alert:

• 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
• 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