Regulatory Affairs Excellence: Structure and Roles in Medical Device Companies

STUDY OVERVIEW

Regulatory Affairs groups ensure that medical device companies comply with global regulations pertaining to developing and marketing medical device products. The effectiveness of a Regulatory Affairs group is, in part, tied to how well its responsibilities are delineated and the group itself is structured.

Best Practices, LLC conducted this benchmarking study to establish meaningful metrics and insights around the structure and roles of Regulatory Affairs groups at medical device companies.

This 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. There are also benchmarks around publishing and translation roles and the impact of 510(k) reform on regulatory resources Additionally, there are qualitative insights on these issues from regulatory leaders in the device sector.

Medical device regulatory leaders can use this study to compare their group structure and roles with those of leading medical device companies.

KEY TOPICS

• Executive Summary
• Participant Background
• Regulatory Affairs Structure
• Regulatory Function Roles and Responsibilities
• Impact of 510(k) Reform

• How is your Regulatory Affairs group structured
• Into which level does your Regulatory Affairs function report
• Average number of direct reports for Regulatory leaders at these five levels
• Does Regulatory Affairs lead, support or play no role for the following (10) responsibilities
• Does Quality lead, support or play no role for the following (10) responsibilities
• Does Regulatory Compliance lead, support or play no role for the following (10) responsibilities
• List the primary responsibilities of your corporate Regulatory Affairs group
• Who handles publishing of regulatory documents
• How do you think new 510(k) reforms will affect your regulatory resources

Publishing, Translations & Storage Solutions: Publishing regulatory documents stay in-house, whether done through a dedicated team or general regulatory resources. Translations are outsourced to third party vendors for most of the benchmark class. A global IT solution handles the storage of regulatory documents.

Concerns about Increased Scrutiny & Reform: Increased regulatory scrutiny is the main concern for Regulatory Affairs executives in the next three years. Additionally, half of respondents feel uncertain about the impact of 510(k) reform on Regulatory Affairs resources.

METHODOLOGY

For this benchmarking study, Best Practices®, LLC gathered insights and performance data from eight regulatory leaders representing eight leading medical device organizations. In addition, executive interviews were conducted with selected participants to produce qualitative insights.

Industries Profiled:
Consumer Products; Medical Device; Chemical; Technology; Health Care; Pharmaceutical; Orthopaedics


Companies Profiled:
Bausch & Lomb; Edwards Lifesciences; BD; Roche Diagnostics; Boston Scientific; Ethicon; Johnson & Johnson; Medtronic; Zimmer

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