Sr. Director, Regulatory Compliance at Medline overseeing quality and compliance for medical products. Leading strategic planning and management of Regulatory –Quality- Laboratory teams.
Responsibilities
Overseeing and directing strategic planning for large and highly complex Regulatory –Quality- Laboratory teams.
Ensuring quality and compliance for applicable products, processes, and services.
Overseeing management of regulatory compliance areas including global regulatory/quality audit process and ethical sourcing audit process.
Provide leadership and expertise in the development of strategies for applicable organizations.
Manage Laboratory business including sourcing, customer contracting, operations, pricing, finance, and competitive strategy.
Drive the strategic development and launch of new services and programs.
Requirements
Bachelor’s degree in Engineering, Science, or Technical Field.
At least 8 years of experience working with QSR/GMP/ISO.
At least 5 years of management experience.
Experience analyzing and reporting data to identify issues and trends.
Experience controlling and coordinating concurrent projects.
Experience controlling and coordinating high-risk regulatory interactions and acquisitions projects.
Position requires travel up to 30% of the time for business purposes (within state, out of state and/or internationally).
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