QA & Regulatory Lead — Medical AI Compliance

ELEM Biotech; Barcelona; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

An innovative biotech company in Barcelona is seeking a Quality Assurance & Regulatory Officer to ensure compliance with quality standards and regulatory requirements. The ideal candidate should have a university degree in a relevant field and at least 2 years of experience in quality assurance or regulatory affairs. Responsibilities include managing documentation, audits, and compliance monitoring. This role offers the chance to work in a cutting-edge environment focused on transforming healthcare through innovative technologies.

Formación

• 2+ years of experience in quality assurance, regulatory affairs, or QMS.
• Applied knowledge of IVDR/MDR and regulatory filings.

Responsabilidades

• Ensure compliance with ISO 13485 and EU IVDR requirements.
• Manage quality documents and complaints.
• Prepare and submit regulatory documentation.
• Conduct audits and inspections of the QMS.

Conocimientos

Proficiency in Quality Assurance principles

ISO 13485:2016 requirements

Regulatory guidelines knowledge (EMA, FDA)

Experience with biomedical software

Fluency in English

Educación

University degree in life sciences or related discipline

Training or certification in quality assurance

Advanced degree in related field

Herramientas

Microsoft Office

AI tools

Descripción del empleo

An innovative biotech company in Barcelona is seeking a Quality Assurance & Regulatory Officer to ensure compliance with quality standards and regulatory requirements. The ideal candidate should have a university degree in a relevant field and at least 2 years of experience in quality assurance or regulatory affairs. Responsibilities include managing documentation, audits, and compliance monitoring. This role offers the chance to work in a cutting-edge environment focused on transforming healthcare through innovative technologies.