Remote IVD/CDx Regulatory Affairs Expert

Parexel; Remoto; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

A global healthcare consulting firm is seeking an experienced Regulatory Affairs professional specializing in in vitro diagnostics (IVD) and Companion Diagnostics (CDx). This role involves developing regulatory strategies, collaborating with cross-functional teams, and managing submissions for regulatory approvals. Candidates must have at least 5 years in Medical Device regulatory affairs, a university degree in a scientific field, and excellent English skills. The position offers flexibility in work location across Europe.

Competenze

• Minimum 5+ years of experience in Medical Device / IVD regulatory affairs.
• Extensive knowledge of international regulations for Medical Devices / IVD, particularly in US and EU.
• Fluent in English, written and spoken.

Mansioni

• Develop and align global regulatory strategies for companion diagnostics.
• Ensure alignment between global and regional IVD and CDx regulatory strategies.
• Lead or support regulatory agency interactions.

Conoscenze

Regulatory affairs

In vitro diagnostics

Companion diagnostics

Collaboration

Regulatory risk assessment

Formazione

University degree in a scientific discipline

Strumenti

Veeva

TrackWise

Descrizione del lavoro

A global healthcare consulting firm is seeking an experienced Regulatory Affairs professional specializing in in vitro diagnostics (IVD) and Companion Diagnostics (CDx). This role involves developing regulatory strategies, collaborating with cross-functional teams, and managing submissions for regulatory approvals. Candidates must have at least 5 years in Medical Device regulatory affairs, a university degree in a scientific field, and excellent English skills. The position offers flexibility in work location across Europe.