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Regulatory Manager (Clinical Trials)
Precision for Medicine
Europe
Regulatory Affairs
ICH GCP
Drug Development
Responsibilities:
- Lead RA efforts for advertising and promotion as well as Dexcom’s software products.
- Review advertising/promotion material and support product classifications.
- Streamline internal processes in compliance to applicable FDA guidance documents and international standards.
Requirements:
- Experience in SaMD regulations, relevant FDA guidance documents, MDCG guidance documents, ISO and IEC standards.
- Excellent writing skills in regulatory documentation.
- Passionate about digital health products in a regulated environment and working knowledge of agile software development methodologies.
Dexcom Corporation
Dexcom Corporation is a pioneer and global leader in continuous glucose monitoring (CGM). They have broadened their vision beyond diabetes to empower people to take control of their health with personalized, actionable insights. Dexcom has thousands of ambitious, passionate people worldwide.