Intern, Regulatory Affairs at Werfen GmbH

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

19 May, 26

Salary

30.0

Posted On

18 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Documentation, IVDD Compliance, IVDR Compliance, Engineering Change Orders, SOPs, SAP, Labeling Review, International Registrations, Quality System Compliance, Analytical Skills, Interpersonal Skills, Microsoft Office, Adobe, Regulatory Research, Customer Request Response

Industry

Medical Equipment Manufacturing

Description

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 Regulatory Affairs Intern will work alongside the Regulatory Affairs Department to gain knowledge and insight into the group and how it fits into the company from a domestic and global standpoint. Responsibilities Key Accountabilities:• 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. Qualifications Minimum Knowledge & Experience required for the position:• 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. Skills & Capabilities:• Basic knowledge of regulatory and compliance requirements, including basics of FDAGMP, 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. Travel requirements:• No travel needed. Acknowledgement:The above statements are intended to describe the general nature and level of work being performed by the incumbent. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of this position. I have read and understand the job description for my position. I agree to comply with the corporate compliance policy and all laws, rules, regulations and standards of conduct relating to my position. For audit, compliance and regulatory purposes, the legal Company name is: Werfen. I understand that this does not constitute or contain a contract or employment promise of any kind. Nothing contained herein modifies the at-will nature of my employment with Werfen. 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

Responsibilities

The intern will compile and update technical documentation for regulatory compliance (IVDD/IVDR), create change orders, and research sales orders in SAP based on regulatory clearances. Responsibilities also include reviewing labeling, compiling documentation for international registrations, and performing administrative regulatory tasks.