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.
Overview
This position provides effective regulatory support for company’s manufactured products and customer’s products. Prepare and submit the documentation according to the corresponding legislation for the different countries. Be responsible for the implementation of new regulatory requirements.
Responsibilities
Key Accountabilities
Prepare the required documentation to obtain the CE mark, FDA,



or other country registrations for the company’s manufactured products or customer’s products in accordance with current legislation. Communication and maintenance of products with Spanish authorities.
Support customers with any regulatory aspect.
Follow up and resolve requirements that emerge during registration procedures.
Maintain technical files as necessary to sustain product approval.
Review product materials, labeling, and/or specification sheets for compliance with applicable regulations and customer policies.
Be part of CFT projects as the RA representative.
Support internal and external audits, validations, and product risk analysis.
Follow management indicators/metrics for the proper performance of the department and apply appropriate corrective actions if necessary.
Support the Market Surveillance Department in compiling information for Post-Market Surveillance.
Recommend and manage, if applicable, changes to company procedures/documents (quality system and compliance) to comply wi

📌 Regulatory Affairs Lead (Cataluña)
🏢 Werfen
📍 Cataluña