Regulatory Affairs Intern

Overview:

Overview:

Ideal candidates will combine technical and business knowledge with analytical strength and creative problem-solving abilities.

Responsibilities:

• Create Change Orders to update regulatory documentation and Standard Operating Procedures as needed
• Support the organization of regulatory files through Werfen’s electronic Regulatory Affairs Database
• Compile documentation to support new regulatory filings to health authorities (including FDA 510(k) submissions and IVDR Technical Files in Europe)
• Perform regulatory administrative tasks as needed

• Currently enrolled in a Bachelor’s or Graduate degree program
• Ability to handle multiple priorities, projects and assignments simultaneously.
• Strong analytical and interpersonal skills.
• Strong proficiency using Microsoft Office (Excel, Word, PowerPoint).
• Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures and processes.
• Other duties as assigned.

Qualifications:

Minimum Knowledge & Experience Required for the Position:

• Currently pursuing B.S. in Regulatory Affairs, Life Sciences, Engineering, Finance, Business, or Marketing with a minimum of 2 college semesters complete.
• Ability to multitask.