Regulatory Affairs Excellence: Staffing & Performance in Medical Device Companies

Best Practices, LLC conducted this benchmarking study to establish meaningful metrics and insights around the structure, activities, roles and responsibilities of Regulatory Affairs groups at medical device companies. The study also provides recent spend and staffing trends of regulatory affairs in medical device sector, including the use of outsourcing and off-shoring.

Medical device regulatory leaders can use this study to align their staff as per strategies of best in class companies for an increased performance delivery.

Study Snapshot

The report is based on the qualitative and quantitative insights of 8 executives from 8 medical device companies. Additionally, three executives shared their knowledge and experiences through deep-dive interviews.

Sample Key Findings

Corporate Regulatory Affairs Groups: Corporate Regulatory Affairs groups average seven FTEs. The groups primarily promote standards, monitor the worldwide regulatory environment, coordinate internal and external policy advocacy efforts, and advise business unit Regulatory Affairs staff.

• Leading Roles & Responsibilities: In addition to handling regulatory submissions, Regulatory Affairs leads labeling/publishing efforts, and FDA listings and registrations, and acts as the official FDA correspondent. Quality leads audits, complaint handling, and responses to FDA 483 observations, to Notified Body observations, and FDA warning letters.

• Future of Regulatory Affairs Function: Most respondents expect the Regulatory Affairs 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.

• Research Objective & Methodology
• Key Findings
• Participating Companies Demographics
• Respondent Background
  • Respondent Demographics
  • Regulatory Affairs Reporting Relationship
• Regulatory Affairs Structure
  • Functional Structure
  • Corporate Regulatory Affairs FTEs
  • Span of Control
• Regulatory Function Activities
  • Active Regulatory Submissions
  • 2010 Filings
  • Filing Trends
• Regulatory Function Roles & Responsibilities
  • Leading & Supporting Roles
  • Corporate Regulatory Affairs Roles
  • Storage, Publishing & Translation Solutions
• Regulatory Function Investment and Staffing
  • 2010 Spend & Staffing
  • Future Resource Trends
• Regulatory Function Outsourcing and Offshoring Trends
  • Regulatory Affairs Growth through Resource Efficiencies
• Impact of 510(k) Reform
  • Impact of Reform on Resources

• Functional executive of regulatory affairs function report
• Structure of regulatory affairs in the company
• Companies have multiple divisions or operating companies
• Companies have a separate corporate regulatory affairs group that is independent of any particular division/operating company, and that serves the needs of the entire company
• Regulatory full time employees (ftes) in the corporate regulatory affairs group
• Average number of direct reports for a dedicated regulatory affairs employee at various levels
• Company’s regulatory submissions actively maintain
• Regulatory ftes and consultants have at various active regulatory submissions
• Total regulatory spend for various submissions in 2010
• Ftes involved in various submissions in 2010
• Consultants ftes involved in various submissions in 2010
• Responsibilities of regulatory affairs functions lead, support, or play no role
• Responsibilities of quality functions lead, support, or play no role
• Responsibilities of regulatory compliance functions lead, support, or play no role
• Responsibilities of corporate regulatory affairs group
• Handling the publishing of regulatory documents in the company
• Handling the translations of regulatory documents in the company
• Companies have a global it solution or system for various activities
• Estimated regional revenues and spend for regulatory affairs in 2010
• Estimated number of in-house ftes and consultants for regulatory affairs in 2010
• Overall regulatory spend/budget changed in the past 3 year
• Overall regulatory headcount changed in the past 3 years
• Regulatory affairs organization to change in next 3 years
• Regulatory affairs organization to grow with internal/ external resources in next 3 years
• Impact of ra organization in the company during the next three years
• Percentage of regulatory spend is allocated to onshore 3rd party outsourcers
• Percentage of company’s regulatory spend is allocated to offshore 3rd party vendors
• Functions or responsibilities are primarily off-shored by the regulatory affairs group
• Expected offshoring levels to grow, shrink, or stay the same in the next 3 years
• New enacted reforms affect the regulatory resources
• New pending reforms affect the regulatory resources