Intern, Regulatory Affairs

Werfen • San Diego, CA

7h • $22 - $30

About The Position

The Regulatory Affairs Intern will work alongside the Regulatory Affairs Department to gain knowledge and insight into the group and how it fits into the company from a domestic and global standpoint.

Requirements

• Currently enrolled in a bachelor’s or graduate degree program with a minimum GPA of 3.2. Preferably in a Regulatory Affairs or Life Sciences major.
• Basic knowledge of regulatory and compliance requirements, including basics of FDAGMP, ISO 13485 regulations, EU MDR 2017/745, EU IVDR 2017/746, MDD 93/43/EC,IVDD 98/79/EC
• Ability to read and interpret domestic and international regulatory/quality standards
• Ability to handle multiple priorities, projects and assignments simultaneously.
• Strong analytical and interpersonal skills.
• Strong proficiency using Microsoft Office (Excel, Word, PowerPoint), and Adobe.

Responsibilities

• Compile and update Technical Documentation for IVDD and IVDR compliance
• Create Engineering Change Orders to update SOPs as needed
• Research and release sales orders in SAP based on regulatory clearances
• Review labeling to comply with international standards
• Compile documentation to support international registrations and tenders
• Respond to external customer requests as needed
• 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