POSITION SUMMARY:

The Regulatory Affairs Co-Op is intended to support the Regulatory team by assisting with day to day tasks and regulatory submissions to the FDA. The Co-Op will be responsible for helping with the organization of documentation and other carious tasks for the department. In addition to calendar management, the individual may perform duties such as coordination of meetings, filing expense reports, and working on special projects. This role may require handling of highly confidential and sensitive information.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Assists with preparation of 510(k)’s, PMA’s, and other regulatory submissions
• Provides support and documentation to international partners in support of international registrations of medical devices
• Maintains internal documentation of domestic and international regulatory approvals
• Creates, edits, and develops visual presentations as needed
• Attends team meetings and other project meetings as necessary
• Completes other tasks and projects as assigned by members of the Regulatory department

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgment
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned

BASIC QUALIFICATIONS:

• High School Diploma or Equivalent
• Pursuing a Bachelor's Degree in Biomedical or Chemical Engineering, Business or a Science
• Have a strong interest in Regulatory Affairs at a Medical Device company
• Computer/data entry Skills
• Verbal Communication Skills
• Proficient in Microsoft Office
• Strong Organizational Skills

PREFERRED QUALIFICATIONS:

• Team oriented
• Able to effectively manage and prioritize multiple projects

OTHER REQUIREMENTS:

• Regularly walk, sit, and stand
• Occasionally bend and push/pull
• Occasionally lift over 25 pounds
• 5% travel potential
• Position dependent upon candidate passing pre-employment physical/drug screen