Proven experience in designing, developing, managing, monitoring, and reporting domestic and international, cutting edge (break-through technology and first-in-man) clinical trials (including Bayesian adaptive designs trials).  Extensive clinical research experience including data analysis, literature searches, white papers, and assistance with writing scientific/medical journal manuscripts.

 Significant regulatory, clinical, and quality experience in various therapeutic areas, including cardiac, cardiovascular, CRM and heart failure, neurovascular, general surgery, general hospital, and orthopedics

 Twenty five years of progressively more responsible experience in positions of Regulatory Affairs, Clinical Research, Quality Assurance, and Manufacturing Engineering in the medical device industry

 Demonstrated ability to develop and implement global regulatory strategies for multiple product lines resulting in commercialization of products in the U.S.A., Europe, Canada, Australia/New Zealand, Japan, other Pacific Rim countries, Central/South America, Middle East, and Africa

 Lead original/supplemental Investigational Device Exemptions (IDEs), Premarket Approval Applications (PMAs), Humanitarian Device Exemptions (HDEs), Class II/III Premarket Notifications [510 (k)s], Regulatory Appeals, Compassionate/Emergency Use, CE Design and Technical Dossiers, Australian Device Registrations, Japan Shonin Applications, and Canadian License Applications/Special Access

 Successfully organized and/or presented at various internal and external high level meetings including: FDA pre-IDE, IDE, pre-PMA, PMA, Supervisory Appeals, and Advisory Panel Meetings; corporate board meetings (board members/investors); meetings with international regulatory agencies (including AFSSaPS in France and MHRA in the UK); Scientific Advisory Board Meetings; and Investigator Meetings

 Expertise designing and managing preclinical studies, analyzing scientific data, and writing medical reports and practical knowledge of biocompatibility and toxicological testing and viral clearance studies

 Comprehensive knowledge and experience in quality assurance and considerable experience in regulatory compliance, including direct responsibility for complaint handling/reporting functions, & design/process verification/validations

 Expertise in regulatory, quality, and clinical due diligence work for various large strategics, equity firms, angel investors, and venture capitalists in the areas of heart failure (CRM), diabetes, general surgery, and others

 Direct experience with ISO and FDA audits/inspections both general audits for compliance or pre-approval inspections for CE or PMA products, respectively

 Knowledge of US and EU reimbursement requirements and experience working with reimbursement consulting specialist to develop initial/top level reimbursement strategies

 Excellent verbal and written communication skills as evidenced by short approval times for product submissions and successful interactions with clients, colleagues, consultants, clinical research organizations (CROs) clinical research organizations, and various regulatory agencies worldwide

 Significant contributor to the development and successful execution of short and long term corporate strategic plans, including performing due diligence evaluations with regards to potential product acquisition and distribution agreements

 Extensive management and supervisory experience in team player with strong analytical and problem solving skills.  Ability to make sound decisions, set and achieve goals, motivate and mentor employees, and exceed deadlines/expectations

Experience

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