Global Regulatory Affairs, Associate Director - UK Regulations Focus (RTP, NC) #4132
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About The Position
The Associate Director of Global Regulatory Affairs & Safety serves as a key point of contact for GRAIL's UK Responsible Person (UKRP). Interfaces with MHRA and other International regulatory agencies, Notified Bodies, and external consultants as needed, on IVD product registrations and audits. Supports US regulatory team and partners with Quality, and relevant cross-functional stakeholders to support UKRP audits, review of promotional material, on-market product support. Creates processes to ensure UKRP functions are adequately performed following procedures and protocols. Monitors and communicates changes in UK and International IVD requirements to project teams and leadership. May be required to manage, lead and provide direction to Regulatory Staff and participate in Senior Management meetings as a delegate.
