Position Summary:
Responsible to lead domestic and/or international registration and renewal activities for Werfen-labeled products. Related duties include participation on design teams, authoring of regulatory assessments for both new products and product modifications, documentation of regulatory impact from device modifications, establishment and maintenance of Technical Files, labeling I advertising review and other regulatory work required to maintain domestic and international compliance.
Key Accountabilities
Essential Functions:
Responsible to participate on design 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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