Global Regulatory Affairs Lead – Diagnostics

Werfen; Cataluña; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Werfen, founded in 1966 and headquartered in Barcelona, Spain, is a world leader in diagnostics. This Regulatory Affairs position provides effective support for regulatory submissions and compliance for our products and customers.

The role involves preparing CE and FDA documentation, liaising with Spanish authorities, maintaining files, and collaborating with R&D and Quality teams to ensure successful regulatory submissions and inspections. Fluency in English and Spanish or Catalan is required.

Formación

• Bachelor’s degree in Life Sciences, Engineering, or Physical Science.
• Any additional degree higher than required is a plus.
• 3 years of experience in a similar position.

Responsabilidades

• Prepare documentation to obtain CE mark, FDA, or other country registrations.
• Communicate with Spanish authorities and maintain regulatory files.
• Support customers with regulatory aspects and follow up on requirements.
• Maintain technical files and ensure compliance of materials and labeling.
• Serve as RA representative in cross-functional projects and assist audits.
• Collaborate with R&D, Quality Operations, and Design Quality to meet submissions.

Conocimientos

Decision making under pressure

Organizational skills

Teamwork

Clear communication

Analytical thinking

Problem solving

Collaboration

Educación

Bachelor’s degree in Life Sciences, Engineering, or Physical Science

Additional degree valued

Herramientas

Excel

Word

SAP

Descripción del empleo

Werfen, founded in 1966 and headquartered in Barcelona, Spain, is a world leader in diagnostics. This Regulatory Affairs position provides effective support for regulatory submissions and compliance for our products and customers.

The role involves preparing CE and FDA documentation, liaising with Spanish authorities, maintaining files, and collaborating with R&D and Quality teams to ensure successful regulatory submissions and inspections. Fluency in English and Spanish or Catalan is required.