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Intern, Regulatory Affairs

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Werfen

3mo ago

  • Internship
    Full-time
    Summer Internship
  • Healthcare
  • San Diego

AI generated summary

  • You should be enrolled in a relevant degree with a GPA of 3.2+, have basic regulatory knowledge, strong analytical skills, and proficiency in Microsoft Office and Adobe.
  • You will update technical documentation for compliance, manage SOP changes, process orders in SAP, review labeling, support registrations, handle customer requests, and maintain quality system compliance.

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 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.

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

FAQs

What is the duration of the internship program?

The internship program lasts for 10 weeks.

What will be the main focus of the internship?

The main focus of the internship will be to gain knowledge and insight into the Regulatory Affairs Department and its role within the company from both a domestic and global standpoint.

What type of tasks will I be performing as an intern?

As an intern, you will compile and update technical documentation for compliance, create engineering change orders, research and release sales orders in SAP, review labeling for international standards, compile documentation for international registrations, respond to customer requests, and perform various regulatory administrative tasks.

What qualifications are required for this internship?

To qualify for this internship, candidates must be currently enrolled in a bachelor's or graduate degree program with a minimum GPA of 3.2, preferably majoring in Regulatory Affairs or Life Sciences.

What skills are necessary for the Regulatory Affairs Intern position?

Necessary skills include a basic knowledge of regulatory and compliance requirements, the ability to read and interpret regulatory and quality standards, strong analytical and interpersonal skills, and proficiency with Microsoft Office and Adobe.

Will I be required to travel during the internship?

No travel is needed for this internship.

Are there any specific regulatory knowledge areas that are preferred for this internship?

Yes, a basic knowledge of FDA GMP, ISO 13485 regulations, EU MDR 2017/745, EU IVDR 2017/746, MDD 93/43/EC, and IVDD 98/79/EC is preferred.

Is there a possibility for full-time employment after the internship?

The job description does not specify the possibility of full-time employment after the internship.

How will my performance be evaluated during the internship?

The internship description does not detail the performance evaluation process, but adherence to the company’s quality system requirements and completion of assigned tasks will likely be important indicators.

What kind of support will I receive during the internship?

Interns will have the opportunity to work cross-functionally with other departments to maximize learning opportunities throughout the program.

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Werfen

Manufacturing & Electronics
Industry
5001-10,000
Employees
1966
Founded Year

Mission & Purpose

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.