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Best Practice Database
Quality, Compliance and Regulatory » Structure,Staffing and Execution
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As regulations and requirements pertaining to approval of new medical devices continue to escalate, organizations are relying more than ever on their Regulatory Affairs function to successfully interact with regulatory agencies. The organizational structure and responsibilities of a Regulatory Affairs group are key factors contributing to its efficiency and effectiveness.
Best Practices, LLC undertook benchmarking research to identify the critical drivers of regulatory excellence, including structure, staffing, and management factors. Regulatory Affairs leaders can use this study to compare their group’s structure and responsibilities with those of leading medical device companies.
· Regulatory Structure
· Regulatory Management Factors
· Structure of Regulatory Affairs
· Regulatory Affairs Staffing Efficiency
· Manufacturing System Profiles
· Executive Reporting of the Regulatory Affairs Function
SAMPLE KEY FINDINGS
• Leadership Reporting: Among all sized-companies, more than two-thirds report directly to the CEO. As companies get very large, a leadership reporting level is often inserted between RA and the C-level. Among the very largest companies, only 50% report that RA still reports directly to the C-level.
Best Practices, LLC recruited Regulatory Vice Presidents and Executives at 32 leading medical device companies to share quality data and regulatory insights regarding current and future trends influencing Regulatory Affairs.