Experience

Rating: 8.9 (Excellent)

Work Experience

2016 - Present

Principal Legal Counsel, Medtronic, Inc.

2014 - 2016

Special Counsel, Covington & Burling

2009 - 2014

Director for Strategic and Regulatory Operations, Food & Drug Administration Fda

2006 - 2009

Associate, Latham & Wakins

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Associations

District of Columbia Bar

Member

Pennsylvania Bar Association

Member

2014 - 2016

American Bar Association chapter

Medical Device Committee Co-Chair

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Education

2005

University of Virginia School of Law

JD - Juris Doctor

2000

University of Pennsylvania

BA - Bachelor of Arts

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Speaking Engagements

2015

Regulation of eHealth Products and Mobile Apps Regulation of eHealth Products and Mobile Apps

2015

Medical device global regulatory intelligence Mhealth

2013

Medical device compliance, regulation, and litigation Significant Recent FDA Actions

2012

Rare diseases and orphan products Impact of FDASIA on Orphan Product Development

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Publications

2015

Covington & Burling Bill Introduced to Streamline and Clarify Combination Product Regulatory Process

2015

Covington & Burling 21st Century Cures Act Passes the House: Contains Key Provisions Related to Medical Devices

2015

Covington & Burlilng FDA Regulation of mHealth Updates

2015

Covington & Burling FDA is Examining Device Risk Assessments in Postmarket Settings

2015

Covington & Burling Important Developments in FDA Regulation of Software, Including Mobile Apps

2015

Covington & Burling FDA Publishes Draft Guidances Describing General Wellness Claims and Risk-Based Classification of Accessories

2015

Covington & Burling 21st Century Cures Discussion Draft Act Proposes Changes to Medical Device Regulation

2014

Covington & Burling FDA Finalizes Appeals Guidance on Section 517A of the Food, Drug, and Cosmetic Act

2014

Covington & Burling FDA Issues Draft Guidance on a Proposed Expedited Access Program for Medical Devices Intended for Unmet Medical Needs

2014

Covington FDA Issues Draft Guidance on Benefit-Risk Considerations

2009

Latham and Watkins Exclusivity Strategies in the United States and Euopean Union

2009

American bar association FDA Issues Clarification of U.S. Clinical Trials Registry Requirements

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Languages

English

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