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 (España)
🏢 Cv-Library
📍 España