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Regulatory Affairs Manager

Roche

Remote, kingdom of spain, Spain Full-time July 20, 2026

Found Description

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 ResponsibilitiesLead and support regulatory strategies for global IVD/MD instrument and software submissions.Ensure compliance with international regulatory requirements and llaborate 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.RequirementsBachelor’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 I...

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