Regulatory Affairs Manager - CDx Systems & Software
Roche(2 months ago)
About this role
A Regulatory Affairs Manager at Roche leading market access for in vitro diagnostic (IVD) products with a focus on Companion Diagnostics systems and software. The role centers on enabling timely regulatory clearance and approvals in major markets—primarily the US and Europe—while working closely with internal and external stakeholders across global teams. The position is based locally in specific sites and contributes to Roche's mission to advance diagnostics and patient access to healthcare.
Required Skills
- Regulatory Submissions
- Stakeholder Management
- Regulatory Strategy
- Companion Diagnostics
- Systems Knowledge
- Software Knowledge
- Project Management
- Audits
- Continuous Improvement
- Leadership
Qualifications
- Bachelor's Degree Life Science or Related
- Master's Degree Life Science or Related
- PhD Degree Life Science or Related
About Roche
roche.comAs a pioneer in healthcare, we have been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally.
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