Senior Clinical & Regulatory Dtr./VP with over 20 years experience in all phases of product development.

Over 20 years of experience working in industry in biopharmaceuticals, and Class II-III medical device development. Perform hands-on management of Clinical Operations, and Regulatory Affairs. Oversee cross-functional product development teams and implement systematic project management techniques for clinical trials to ensure alignment with overall product development timelines and market release. Instill continuous quality improvement measures through routine assessments of standard operating procedures, employee training, and proactive risk management. Understanding the marketplace and regulatory requirements, create strategic development plans for the entire life cycle of products in accordance with business needs. Working with the management team, create robust evidence development plans to support reimbursement and drive market adoption through effective clinical trial designs and publications. Compile, submit, and negotiate 510(k), IDE, PMA, applications. Prepare and submit EU product registrations and approvals to include development of technical dossiers for CE Mark. Operationally, develop and manage trial budgets; hire and provide hands-on daily management of all members of the extended team to include all roles participating in clinical trial execution; CRAs, Data Management, Biostatistics, Safety Monitoring, Regulatory Specialists, virtual team members within and outside of the US; and contracted consultants and vendors (central labs, safety monitors, database administration, etc.).

Clinical Regulatory Affairs