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Chris Paulik

Regulatory Affairs Manager at GE Healthcare
Healthcare
And Home Health Care
Hungary

Biography

Prepare, develop, and maintain regulatory submissions (e.g. 510K) for medical devices in the X-Ray division, including documenting decisions to not file for pre-market clearance/approval. Review promotional material and device labeling for regulatory compliance. Participate as the Regulatory Affairs contact for cross-functional New Product Introduction teams. Coordinate clearance/approval to ship X-Ray products to foreign countries with global Regulatory Affairs colleagues.

Research Interest

Regulatory Affairs Manager at GE Healthcare

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