Co-op, Regulatory Affairs

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