Overview:

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.   

Throughout the 10-week program, students will have the opportunity to work cross functionally with other departments to maximize their opportunity to learn as much as possible.

Position Description

• • 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. 

Minimum Knowledge & Experience Required for the Position:

• 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. 

Skills & Capabilities: 

• Basic knowledge of regulatory and compliance requirements, including basics of FDA GMP, 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. 

Travel requirements: 

• No travel needed.  

Acknowledgement: 

The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. 

I have read and understand the job description for my position. I agree to comply with the corporate compliance policy and all laws, rules, regulations and standards of conduct relating to my position. 

I understand that this does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of my employment with Werfen.