Robert Greil Email & Phone Number

Pittsburgh, Pennsylvania, United States

Indianola, PA

• Conducted thorough research on available Regulatory Information Management System (RIMS) solutions, evaluated and selected the most suitable vendor, and negotiated a contract that met the business requirements and.
• Spearheaded the digital transformation and modernization of the Bayer Radiology Regulatory Affairs department by developing and executing a comprehensive project plan that ensured the successful implementation of a.
• Coordinated with cross-functional teams to ensure alignment of all regulatory business units, IT teams, and other stakeholders, leading to seamless integration of the RIMS solution across the organization.
• Served as a member of the project team for the Iceberg Program, a major R&D and Product Supply initiative, and contributed to the successful implementation of Windchill PLM for documents and parts under a CM2 change.
• Established performance metrics and key performance indicators (KPIs) to track the effectiveness of key processes, increase regulatory compliance and data accuracy, and streamline time to market.
• Maintained UDI compliance for the radiology portfolio, including implementing process improvements and automation, monitoring and updating UDI data, and conducting UDI process audits to ensure adherence to regulations.

Indianola, PA

• Oversaw all labeling initiatives for sterile disposable (SD) products, maintaining compliance with global regulations and ensuring the continued supply of 60+ SD products to global markets, while collaborating with.
• Contributed to the sustainability of the CT Product Family by leading cross-functional teams in planning and executing design changes, managing budgets, allocating resources, overseeing schedules, reporting program.
• Championed the development of a symbols-based label design conforming to global regulations, establishing it as the new norm for new products and achieving a ~40% decrease in the number of SKUs to maintain during the.
• Managed the successful implementation of new injection molding technology, resulting in an annual cost savings of ~$330k, a 58% reduction in cycle time, improved visual appearance, minimized scrap, and optimized.
• Evaluated the technical readiness and adherence to Quality Management System (QMS) standards for various new product launches as a Technical Review Board (TRB) member.

Indianola, PA

• Qualified an alternate manufacturing site for LPCT by creating engineering drawings, contributing to label design, conducting verification testing, and performing technical reviews as the Chief Engineer / Technical Lead.
• Performed cross-functional design reviews, functional testing, statistical analysis, and design verification reports to support the qualification and regulatory clearance of a fluid filter to solve a major safety issue.
• Supported the department SharePoint site with monitoring KPIs, request intake, and detailed technical information.
• Contributed to the successful FDA 510(k) submission and approval as a subject matter expert in sterile disposables.

Indianola, PA

• Aided new product development with functional testing of a new product line
• Executed risk reduction testing to evaluate two alternate materials for production
• Led the implementation of UDI on sterile disposables packaging for compliance with new FDA regulations
• Authored and implemented a technical evaluation form to be used in product non-conformance investigations
• Monitored as-reported customer complaints for trends/spikes to improve process/design of products
• Analyzed quantities and spend of resins in conjunction with procurement to identify cost reductions and minimize risks

Coraopolis, PA

• Oversaw local municipalities implementation of the MS4 program for surface water engineering and quality controlam
• Conducted NPDES storm water samples of residential and commercial facilities
• Operated VRS and conventional equipment for construction stakeouts and topographic surveys
• Generated MS4 summary reports and presented findings to local municipalities
• Created drawings using AutoCAD and GIS to map out storm water outfall locations