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Structure of Regulatory Affairs in Medical Device Companies Impacting Organizational Efficiency

CHAPEL HILL, N.C., Jan. 31, 2014 /PRNewswire/ -- Ensuring that companies comply with the plethora of global regulations pertaining to developing and marketing new medical device products is a challenge faced by many organizations. To cope with these challenges, Regulatory Affairs groups rely on their own internal effectiveness and efficiencies to remain productive and to support their organization's goals. Despite this, leaders are still struggling to know the optimal resourcing and staffing levels to prioritize the roles and responsibilities that will be most beneficial for growth.

The effectiveness of Regulatory Affairs groups within the medical device industry is directly tied to how well its responsibilities are prioritized and how the group itself is structured. According to recent research from benchmarking firm, Best Practices, LLC, a hybrid structure – one that centralizes planning, information, and coordination, but not staff – may help to increase overall efficiency.

The report, "Regulatory Affairs Excellence: Staffing & Performance in Medical Device Companies," examines the structure and roles of Regulatory groups at medical device companies. The report also provides leaders with meaningful metrics around Regulatory affairs' spend, FTEs and consultants for medical device operations in the U.S. and globally.

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

This benchmarking research drew participation from eight executives from eight medical device companies. In addition, deep-dive interviews were conducted with three executives to gather additional insights.

To access the full report, or to download a complimentary summary containing insights found in this report, click on the following link: http://www3.best-in-class.com/rr1167.htm.

For more information on other recent primary research studies, contact us at 919.403.0251. For related research, visit our Best Practices, LLC website at http://www.best-in-class.com/.

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. The operational insights, findings and analysis form the basis for our Benchmarking Reports, databases and advisory services to support executives in commercial and R&D operations. Best Practices, LLC believes in the profound principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies.

SOURCE Best Practices, LLC

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