Boston Scientific Corporation: Vice President, Global Regulatory Affairs
Medical Device Consultants, Inc: Director, Global Regulatory Services
Food and Drug Administration: Scientific Reviewer, Surgery, Orthopedic and Restorative
Devices Branches
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- A track record of productive meetings with FDA reviewers across CDRH. Excellent relationship with premarket and postmarket FDA staff.
- Managed US and foreign clinical studies from start to finish - strategy and planning, recruiting investigators, qualifying investigational sites, writing clinical study documentation, working with CROs for study monitoring and management, data analysis, report writing, and presentation to regulatory authorities.
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Implemented regulatory and compliance systems to improve product and process quality including a regulatory submission quality control process, regulatory submission tracking database, product incident review process for potential field action/recall, complaint handling and MDR/vigilence reporting process.
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Delivered training on a variety of regulatory and compliance topics, including global regulatory submissions, changes in the FDA 510(k) program, clinical study requirements, postmarket surveillance, medical device advertising and promotion issues, MDRs, recalls, design and process controls, and risk management.
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