Regulatory Affairs Specialist - Global Compliance

Werfen Immunoassay; Lliçà d'Amunt; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Werfen Immunoassay seeks an Regulatory Affairs Lead to provide regulatory support for our products and our customers. You will prepare and submit documentation according to country legislation and implement new regulatory requirements.

Responsibilities include CE/FDA registrations, maintaining technical files, reviewing materials for compliance, supporting audits, and collaborating with R&D, Quality Operations, and other teams to ensure successful regulatory submissions.

Formación

• Degree in Life Sciences, Engineering, or Physical Science required or substituted by relevant skills and experience.
• 3 years in a similar regulatory role required.
• Knowledge of IVD legislation or healthcare sector is valuable.

Responsabilidades

• Prepare documentation to obtain CE, FDA, or other country registrations for products.
• Maintain technical files to sustain product approvals.
• Review labeling and specifications for regulatory compliance.
• Support audits, validations, and risk analyses.
• Collaborate with R&D, Quality Ops, Design Quality, and Operations on submissions.
• Ensure all documents are RA-reviewed before external sharing.

Conocimientos

Decisions under pressure

Methodical

Teamwork

Clear communication

Regulatory thinking

Attention to detail

Educación

Bachelor's degree in Life Sciences/Engineering/Physical Science

Herramientas

SAP

Microsoft Office

Descripción del empleo

Werfen Immunoassay seeks an Regulatory Affairs Lead to provide regulatory support for our products and our customers. You will prepare and submit documentation according to country legislation and implement new regulatory requirements.

Responsibilities include CE/FDA registrations, maintaining technical files, reviewing materials for compliance, supporting audits, and collaborating with R&D, Quality Operations, and other teams to ensure successful regulatory submissions.