Job Description

Internship Opportunity

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.

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

Key Attributes

• 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.
• Other duties as assigned.

Qualifications

• 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.

The hourly range for this role is $22/hr to $30/hr. Individual compensation will ultimately depend on factors including relevant experience and grade level completed.

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

Job Tags

Similar Jobs