Join Roche as an International Regulatory Affairs Professional to drive regulatory solutions for global IVD/MD instruments and software. Bring your expertise in regulatory strategy, compliance, and cross‑functional collaboration to impact patient care worldwide.

Key Responsibilities

Lead and support regulatory strategies for global IVD/MD instrument and software submissions.

Ensure compliance with international regulatory requirements and standards.

Collaborate with cross‑functional teams (R&D;, Quality, Clinical) to drive regulatory initiatives.

Provide regulatory guidance to support product development and lifecycle management.

Stay abreast of evolving regulatory trends and implement best practices.

Requirements

Bachelor’s Degree in Life Sciences, Regulatory Affairs, or related field.

5 to 7 years of experience in Regulatory Affairs (Regulatory, R&D;, Quality, and/or Clinical),



preferably in healthcare regulatory affairs.

In‑depth knowledge of global regulatory requirements, guidelines, and procedures for IVD instruments and software.

Strong organizational and communication skills.

Ability to multitask and manage multiple projects simultaneously.

Self‑motivated and able to work independently in a self‑management environment.

Experience with IVD instrument and/or software development.

Benefits

Collaborative and innovative work environment.

Opportunity to make a meaningful impact on patients’ lives globally.

Competitive compensation and benefits package.

Professional development and growth opportunities within a leading integral healthcare organization.

Roche is an Equal Opportunity Employer.

📌 Regulatory Affairs Manager (Madrid)
🏢 Roche
📍 Madrid