What are the responsibilities and job description for the Regulatory Affairs Intern position at Werfen?
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.
Responsibilities
Position Description
- 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
Minimum Knowledge & Experience Required for the Position:
- 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.
Closing
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.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.
www.werfen.com
Salary : $2 - $30