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.

Todas las habilidades, cualificaciones y experiencia relevantes que necesitará un candidato seleccionado se enumeran en la siguiente descripción.
Key Responsibilities

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- Lead and support regulatory strategies for general 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

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- 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

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- 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 global healthcare organization. xhfqzwm

Roche is an Equal Opportunity Employer.

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📌 Regulatory Affairs Manager (Barcelona)
🏢 Roche
📍 Barcelona