Global Regulatory Affairs Lead

Actual Talent; Barcelona; Presencial; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

Werfen, a growing diagnostics company founded in 1966 in Barcelona, Spain, provides regulatory support for its own and customer products. This role ensures documentation is prepared and submitted according to country legislation and that new regulatory requirements are implemented.

Key accountabilities include obtaining CE and FDA registrations, maintaining technical files, reviewing materials for regulatory compliance, serving as RA representative in cross-functional teams, and supporting

Formación

• Bachelor’s degree in Life Sciences, Engineering, or Physical Science.
• 3 years in a similar regulatory/RA position.
• Fluency in Spanish or Catalan; advanced English.
• Knowledge of IVD legislation and healthcare sector.

Responsabilidades

• Prepare and submit regulatory documentation for CE, FDA, and other registrations.
• Maintain technical files to sustain product approvals.
• Review materials labeling and specs for regulatory compliance.
• Be RA representative in cross-functional teams.
• Support internal and external audits, validations, and post-market surveillance.
• Collaborate with R&D, Quality Operations, Design Quality, and Operations.
• Ensure RA reviews before sharing documents externally.

Conocimientos

Decision making

Organization

Teamwork

Clear communication

Systematic approach

Analytical thinking

Collaboration

Company values

Educación

Bachelors Life Sciences/Engineering/Physical Science

Herramientas

Excel

Word

SAP

Descripción del empleo

Werfen, a growing diagnostics company founded in 1966 in Barcelona, Spain, provides regulatory support for its own and customer products. This role ensures documentation is prepared and submitted according to country legislation and that new regulatory requirements are implemented.

Key accountabilities include obtaining CE and FDA registrations, maintaining technical files, reviewing materials for regulatory compliance, serving as RA representative in cross-functional teams, and supporting