Regulatory Affairs Lead

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. We operate directly in 30 countries, and in more than 100 territories through distributors.

Our Headquarters are in Barcelona, Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded €2.2 billion in 2024, and our workforce is more than 7,000 strong.

Job Summary

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.

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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 with current regulations, guidelines, and/or standards.

• Provide support to Customer Service regarding product import/export.

• Ensure effective partnering and collaboration with R&D, Quality Operations, Design Quality, and Operations to meet project goals, maintain compliance, and complete defined regulatory submissions.

• Ensure all documentation is RA-reviewed before it is shared externally with regulators and/or customers.

• Collaborate with other QRA groups, R&D, and Operations to ensure successful Regulatory Inspections.

Networking / Key Relationships

To be determined based on department needs, to include interactions such as:

• All departments of the company.

• Werfen Companies.

• Customers.

• Regulatory agencies.

• Suppliers.

Minimum Knowledge & Experience Required

Education:

• Required: Bachelor’s degree (diplomatura) in Life Sciences, Engineering, or Physical Science. Degree may be substituted by relevant skills and work experience.

• Valuable: Any additional degree higher than required.

Experience:

• Required: 3 years in a similar position.

Additional Skills / Knowledge:

• Software: Fluency in Office Tools (Excel & Word); basic knowledge of SAP is valuable.

• Languages: Fluency in Spanish or Catalan; advanced knowledge of English (reading and speaking).

• Standards: Knowledge of IVD legislation and the healthcare sector is valuable.

(Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement).

Skills & Capabilities:

• Management of decisions under pressure.

• Methodical and well-organized approach.

• Teamwork.

• Time management skills.

• Ability to express information clearly and concisely to staff, ensuring understanding.

• Ability to apply a systematic approach with constant control, follow-up, and verification of results.

• Analytical thinking and problem-solving.

• Ability to collaborate, participate, and coordinate actively with working groups.

• Reflects Werfen values in work quality and working relationships.

Travel Requirements:

• Up to 5% of time.