Regulatory Intern

OrthoPediatrics • Warsaw, IN

4d

About The Position

GENERAL SUMMARY: The Intern will be responsible for providing general regulatory, clerical, and administrative assistance for the Regulatory and Clinical Affairs team while also gaining on-the-job training that will assist him/her with his/her future career search.

Requirements

• Excellent verbal and written communication skills
• Able to work independently or on teams
• Easily adapts to new technology and applications
• Experience using office software tools and applications
• Ability to work with minimal to moderate supervision
• Ability to manage multiple projects and deadlines
• Problem solving skills required
• Currently enrolled in a degree-seeking program from an accredited college or university. Technical or science focus preferred.
• Ability to read and comprehend instructions, correspondence, and memos.
• Ability to communicate effectively with team members, internal customers, and other employees of the organization. Requires excellent grammar and spelling.
• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
• Requires a valid driver’s license.
• Requires the ability to operate a variety of standard office equipment, such as a computer and keyboard, calculator, fax, photocopier, telephone, cell phone, etc.
• Requires proficiency with Microsoft Word, Excel, Outlook and PowerPoint.

Responsibilities

• Gain knowledge of OP medical devices and governing regulatory requirements.
• Assist in the research and compilation of registration documentation.
• Assist in the research, assessment and analysis of changes impacting regulatory status of OP devices.
• Participate on and assist the Regulatory team for Regulatory-driven projects and work-streams
• Data management (compilation, verification, gap-analysis)
• Initiation/creation of infocards and change requests in the OP document management system
• Gain knowledge of OP medical devices and governing regulatory requirements.
• Partner with cross-functional team members in the performance of daily activities, including Quality, Operations, Engineering, and Sales.
• Assist in 3rd Party Audit activities by supporting backroom leader (document pull, runner, logistics coordination)

What This Job Offers

• Career Level: Intern
• Education Level: No Education Listed