Benchmarking Regulatory Affairs in Medical Devices: Structure and Management

STUDY OVERVIEW

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.

KEY TOPICS

· Regulatory Structure
· Regulatory Management Factors

KEY METRICS

· 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.

METHODOLOGY

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.

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.