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