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Regulatory Affairs Intern

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Werfen

2mo ago

  • Internship
    Full-time
    Summer Internship
  • Research & Development
    Healthcare
  • Bedford, +1

AI generated summary

  • You must be enrolled in a relevant degree program, proficient in Microsoft Office, able to multitask, and have strong analytical and interpersonal skills. Two semesters completed are needed.
  • You will update regulatory documentation, organize files, compile submissions for health authorities, perform administrative tasks, and ensure compliance with quality systems and procedures.

Requirements

  • 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.
  • 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.

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

FAQs

What is the location for this internship?

The internship is located in Bedford, Massachusetts, at 180 Hartwell Road.

What type of internship is being offered?

This is a paid internship in the Regulatory Affairs department.

What are the main responsibilities of the Regulatory Affairs Intern?

The main responsibilities include creating Change Orders for regulatory documentation, organizing regulatory files, compiling documentation for regulatory filings, and performing regulatory administrative tasks as needed.

What qualifications are required for this internship?

Candidates must be currently pursuing a Bachelor’s or Graduate degree in Regulatory Affairs, Life Sciences, Engineering, Finance, Business, or Marketing, with at least 2 college semesters completed.

Are there any specific skills required for this position?

Yes, candidates should possess strong analytical and interpersonal skills, the ability to multitask, and proficiency in Microsoft Office applications such as Excel, Word, and PowerPoint.

Is previous experience in regulatory affairs necessary for this internship?

Previous experience is not explicitly required, but candidates should demonstrate leadership potential and a strong academic performance.

How should applicants submit their application?

Interested applicants should submit their resume or CV for consideration.

What opportunities for growth does this internship provide?

The internship offers meaningful hands-on experience in the field, allowing students to develop technical, business, and analytical skills in a regulatory affairs setting.

Is Werfen an equal opportunity employer?

Yes, Werfen is committed to a diverse workplace and prohibits unlawful discrimination, harassment, or retaliation based on protected characteristics.

What is the annual revenue and size of Werfen?

Werfen has an annual revenue of approximately $2 billion and employs more than 7,000 people worldwide.

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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.