OverviewYou will help bring life-changing diagnostic solutions to market by leading regulatory submissions within Roche's Oncology IVD team.

You collaborate with cross-functional partners and external regulators to navigate global regulatory pathways.

The role emphasizes agility, problem-solving, and continuous improvement to streamline market access.

This is a chance to influence healthcare access worldwide while growing in a supportive, value-driven culture.

ResponsabilidadesLead and coordinate preparation of registration dossiers for moderately complex products or programs

Develop regulatory submission plans to secure global market access

Apply integral regulatory knowledge (IVDR, FDA, ISO ) to ensure compliant pathways

Build and maintain collaborative relationships with internal partners and regulatory bodies

Support inspection and audit readiness, execution, and corrective actions





Identify bottlenecks and propose practical improvements; explore digital tools and automated workflows

Demonstrate VACC leadership and agile mindset to foster an inclusive, high-trust team environment

Requisitos principalesBachelor's or Master's degree in a relevant life sciences field

1+ years of regulatory affairs, quality assurance, R&D;, or clinical operations experience

Proficiency in MS Office and Electronic Document Management Systems (EDMS/RIMS)

Fluency in English (written and spoken) with clear regulatory communication strong communication collaboration across cross-functional teams autonomy and initiative

MS Office

EDMS/RIMS knowledge of IVDR, FDA regulations, and ISO

📌 Regulatory Affairs Specialist (Barcelona)
🏢 Roche
📍 Barcelona