Regulatory Affairs Intern

Werfen • Bedford, MA

21h • $22 - $30

About The Position

Introduction Werfen 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. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview 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.

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

• 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