Regulatory Affairs Intern

Werfen • Bedford, MA

5h • $22 - $30

About The Position

Overview:
The purpose of the internship is to provide meaningful professional hands-on experience to students with leadership potential and proven academic performance. Werfen hires students majoring in Engineering and Life Sciences fields into this internship program based on business need. Ideal candidates will combine technical and business knowledge with analytical strength and creative problem-solving abilities.
Position Description
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
Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures and processes.
Other duties as assigned.

Requirements

• 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.

Nice To Haves

• 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).

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
• Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures and processes.
• Other duties as assigned.

What This Job Offers

• Career Level: Intern