Position Summary:
Responsible for domestic and/or international registration and renewal activities for Werfen-labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising review and other regulatory work required to maintain domestic and international compliance.
Key Accountabilities
Essential Functions:
Responsible to participate on design and risk management teams (both Hemostasis and Acute Care Diagnostics) as the Regulatory representative and provide guidance on domestic and international requirements, including:
Budget Managed (if applicable):
Internal Networking/Key Relationships:
Skills & Capabilities:
Minimum Knowledge & Experience Required for the Position:
International Mobility: Required:
Travel Requirements:
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