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Staffing and Performance Benchmarks for Regulatory Function Highlight New Medical Device Study

CHAPEL HILL, N.C., Aug. 17, 2012 /PRNewswire/ -- Regulatory Affairs groups face the monumental task of ensuring that companies comply with the plethora of global regulations pertaining to developing and marketing medical device products. These specialized groups largely rely on their own internal effectiveness and efficiencies to remain productive and support the organization's goals.

Optimal resourcing and staffing help Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth. Likewise, the effectiveness of a regulatory group also is tied to how well its responsibilities are delineated and the group itself is structured

In a recent study, Regulatory Affairs leaders said they expect the function to grow during the next three years through a combination of internal and external resources. However, few expect outsourcing and off-shoring to increase beyond current levels, according to the research project.

Research and consulting firm Best Practices, LLC conducted this benchmarking study, Regulatory Affairs Excellence: Staffing & Performance in Medical Device Companies, to establish meaningful metrics around Regulatory Affairs' spend, FTEs and consultants for medical device operations in the U.S. and globally. The 91-page study also examines the structure and roles of regulatory groups at medical device companies.

This study addresses critical Regulatory Affairs benchmarks for:

  • Global Resource Levels - including optimal budget and staffing allocations
  • Organizational Structure
  • Span of Control for managers to VP
  • Regulatory Submissions and Trends
  • Leading & Supporting Roles of Regulatory Affairs
  • Outsourcing/Offshoring for electronic storage, publishing, and translation services
  • Impact of 510(k) Reform

The study results will benefit Regulatory Affairs leaders by providing evidence-based staffing, budget, and activities benchmarks and insights that can't be found in market research databases or journal articles, helping you determine how your Regulatory Affairs function is performing respective to those at other leading medical device organizations.

Staff and budget benchmarks are presented per Class I, II and III device products on the market, submissions actively maintained in 2010 and product applications submitted in 2010.

In addition, the study presents benchmarks around organizational structure to provide insights around reporting lines and span of control. In terms of the role of Regulatory Affairs, the research study presents data showing the role (lead, support or no role) of regulatory, regulatory compliance and quality across 10 key responsibilities.

To access the full report or to download a complimentary summary containing insights found in this report, click on the following link:


Best Practices, LLC is a leading benchmarking, consulting and advisory services firm serving biopharmaceutical and medical device companies worldwide. Best Practices, LLC's clients include all the top 10 and 48 of the top 50 global healthcare companies. The firm conducts primary research and consulting using its comprehensive proprietary benchmarking tools and analysis.

SOURCE Best Practices, LLC
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