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 integral 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 global healthcare organization.
Roche is an Equal Opportunity Employer.

📌 Compliance Manager/Senior Manager (España)
🏢 Roche
📍 España