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• Provided oversight of clinical studies and technology implementation for coagulation and clinical laboratory instruments• Directed both Regulatory Affairs and Scientific Affairs teams• Formulated functional strategies for regulatory submissions, test method comparison studies, institutional clinical partners, goals, budgets, and objectives for the organization• Developed and implemented regulatory compliance policies and procedures• Responsible for the planning and execution of FDA 510(k) filings and formal responses• Confirmed compliance with ISO standards and regulations, conducting regular audits and assessments• Identified risks and concerns early in the process, proactively advising headquarters• Collaborated with colleagues in France to develop automated solutions for change notifications• Developed enhanced training for Clinical Research Associates on rare diseases• Grew successful relationships with FDA officials while negotiating labeling and clearance requirements.

Provide strategy and leadership for Thermo Fisher regulatory staff in product support area for the safe distribution of over 900,000 scientific laboratory products, (pharmaceuticals, biopharmaceuticals/bioactive, excipients, antibodies, medical devices, dual use military equipment and protective clothing) Managed FDA medical device and facility registrations. Provide guidance to other Thermo Fisher-owned businesses for obtaining Federal and State licenses and permits. Directed a team of professionals responsible for chemical hazard communication; dangerous goods transportation; international regulatory compliance; cGMP/cGDP; alcohol and explosives; controlled substances and other regulated chemical precursors; chemical weapons and chemical registration in the EU, U.S. and elsewhere. Provide regulatory awareness training for internal and external customers regarding compliance with Federal, state and local laws and cGMP regulations. Increased the cohesiveness of Regulatory group within the U.S., Europe, Asia and Australia through regulatory educational and compliance reviews, audits and ERP implementation.• Responsible for and integrated Regulatory Affairs Teams in North America, Europe, India and China. • Developed regulatory policies and procedures for international compliance programs. • Advise executive leadership team on upcoming regulatory issues and recommend response strategy.• Assure regulatory compliance related to Food and Drug Administration, Drug Enforcement Agency and State Boards of Pharmacy.• Direct product regulatory teams to implement MSDS/labeling system for products in 30 languages. • Implemented Standard Operating Procedures relating to new or changing State or Federal regulations for the US and international operations. • Researched and interpreted government rulings on regulation and compliance changes.

Vice President of Regulatory Affairs, Quality Assurance and Health, Safety, Security and Environmental. Severed as Executive Committee member of EMD Chemicals Inc., a $400 million specialty chemical manufacturer. EMD is an affiliate of Merck, KGaA, Darmstadt, Germany, a global chemical and pharmaceutical manufacturer. Responsible for a budget of ≈ $2.0 million per annum.