Regulatory Affairs Lead

On-site in Spain·Full-time·Added today

Werfen

37 open roles

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Overview

Job details

Full-time hours
Per the ad.

Requirements

Have the right to work in Spain
Werfen doesn't mention sponsorship in the ad.
Speak fluent Spanish
Listed as a requirement in the ad.
Work in English
English is required, per the ad.
Work on-site in Spain
No relocation package mentioned.
Have 3+ years of experience
Mid-level role.

The role

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.

What you'll do

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.

Job Information

Number

Job function

Job type

Full-time

Location

Lliçà d'Amunt, Cataluña, España

Country

Spain

Internal Networking

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

All departments of the company.
Werfen Companies.
Customers.
Regulatory agencies.
Suppliers.

Requirements

What we're looking for

Degree/studies
- Required: Bachelor's degree (diplomatura) in Life Sciences, Engineering, or Physical Science.
- Valuable: Any additional degree higher than required.
Years of experience
- Required: 3 years in a similar position.
Min 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 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.

About Werfen

Werfen is a global medical diagnostics company headquartered in Barcelona, Spain, specializing in in vitro diagnostic systems and reagents for hemostasis, acute care, transfusion, autoimmunity, and transplant. With direct operations in 30 countries and distribution in over 100 territories, the company generated nearly €2.2 billion in sales in 2024 and employs 7,000 people worldwide. Its technology centers are located in the United States and Europe, and it recently acquired Omixon, a Budapest-based NGS company, to expand its transplant diagnostics portfolio.

Industry: Medical Diagnostics
Founded: 1966
Employees: 5,000–10,000
Headquarters: Barcelona, Spain
In Spain: Barcelona
Website: werfen.com

Good to know if you are moving

Headquartered in Barcelona, Spain, offering a Mediterranean lifestyle and a major European tech and business hub.
Operates in 30 countries directly, providing potential international mobility opportunities within the company.
Family-owned and innovative, with a strong focus on R&D and technology centers in the US and Europe.
Workforce of 7,000 employees, indicating a large, established organization with diverse roles.
Recent acquisition of Omixon (Budapest) may create new opportunities in NGS and transplant diagnostics.

In their own words

About the company & team

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.