Compliance Specialist supporting various Compliance initiatives and ensuring regulatory adherence in healthcare. Reporting to the Compliance Manager and collaborating with internal departments on compliance - related projects.
About the role
- 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).
Benefits
- health insurance
- life and disability
- 401(k) contributions
- paid time off
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