Dr Josephine Bautista
Director, Regulatory Affairs
Josie is well versed in regulatory and clinical laboratory sciences and management, with over 30 years of experience in both the private sector and the Federal Government.Read More
Other career highlights include work at Walter Reed Army Medical Center as Laboratory Manager for the Stat Lab and Hematology/Coagulation Division, Laboratory Manager for Maryland Medical Laboratories (now Quest Diagnostics), and Acting Director and Associate Director of the Hematology and Immunology Division in the Office of In Vitro Diagnostic Device Evaluation and Safety and the Associate Director of Compliance at the Center for Devices and Radiological Health (CDRH). Prior to joining Goldbug Strategies, Josie was Senior Staff for Regulatory Affairs in the Molecular Diagnostic Division of Beckman Coulter.
Just prior to joining Goldbug Strategies, Josephine was Senior Staff for Regulatory Affairs in the Molecular Diagnostic Division at Beckman Coulter where she had responsibility for all interactions and submissions to the FDA and international regulatory agencies.
Christine Bump, JD, MPH
Vice President, Strategy
Christine has expertise in decoding and driving the process of medical device regulation for our clients. With emphasis on laboratory developed tests, genetic tests, personalized medicine products, and wellness products at the intersection of FDA and CLIA regulatory policy.Read More
Previous career highlights include working for the Center for Disease Control and Prevention, Hyman, Phelps & McNamara, PC, and Goodwin Procter LLP. Christine was recognized by SuperLawyers as a “Rising Star” in Food and Drug Law, and earned a B.A. with High Honors from Sweet Briar College. She earned a J.D. and M.P.H. from Emory University’s Schools of Law and Public Health, where she was Executive Managing Editor of the Emory International Law Review.
Vice President, RA/QA Portfolio
Joel has over 17 years experience in molecular diagnostics, medical devices and bio-implants.Read More
Chief Operating Officer
Chris has served in leadership roles in healthcare, research, and government sectors as COO and CFO. He has expertise in building the organizational capacity of growing sustainable and profitable companies with special interest in driving new technology and innovation to market.Read More
Chris attended Cornell University where he graduated with a BA with Distinction and Johns Hopkins University where he earned a Masters in Health Science (MHS) concentrating in Health Finance and Management.
Rick has 20 plus years of experience in medical devices, diagnostics, and software; and has specific interest and expertise in Quality System Implementation, ISO 13485, Supplier Auditing, Management Review, and CAPA.Read More
Office Manager, Client Relations
Ari is the right hand for Goldbug’s Founder & CEO and helps keep things running smoothly.Read More
Ulyana is Goldbug Strategies’ Controller responsible for accounting operation and financial information of the Company. As a part of the team, Ulyana contributes to the wide range of decision making processes and provides financial analysis of various outcomes.Read More
Chief Financial Officer
Stuart has more than 30 years’ financial and operations expertise, including numerous capital raises, M&A transactions and two IPOs. He has extensive experience resolving complex accounting issues, structuring transactions, and streamlining back office operations for companies ranging from start-ups to mature organizations.Read More
Stuart spent the first 10 years of his career with Arthur Andersen, LLP, providing financial services, hospitality, government contracting, transportation, technology and healthcare clients standard audit and advisory services while also working on numerous M&A, and capital raising transactions. He subsequently served as CFO or VP-Finance for several publicly traded and privately held high tech, Internet, government contracting, energy and professional services firms, including the world’s largest solar-thermal power provider.
Jessica Roth, MPH
Jessica is a reimbursement policy expert who has served as director of health policy in different settings including a law firms, Pharma companies, and non-profits.Read More
Wendy is a regulatory affairs leader with over 20 years diverse experience in Medical Devices, In Vitro Diagnostics, Prescription Drugs, Electrotechnical Devices, and Over-the-Counter Medicines.Read More
Kelli Tanzella, PhD
An experienced Regulatory Affairs professional with complex project management skills, Kelli has detailed expertise in related post-market quality audits, FDA inspections, regulatory submissions and approvals (including PMAs). Kelli also has done high level work with international agencies.
Sheila D Walcoff, J.D.
CEO and Founder
As a health and science attorney with over 20 years of experience in Washington, DC, Sheila understands the complexities of the health and science industry, as well as the intricacies of the legal and regulatory system.Read More
Sheila is a life-long entrepreneur and has started, built, and sold several businesses in addition to Goldbug Strategies.
Judy has a long and distinguished career as an executive and consultant in Clinical Sciences and Laboratory Operations.Read More
Michael has deep knowledge of the FDA and CMS Regulatory issues as he has previously worked as a Bloomberg BNA reporter covering medical devices and Medicare Part A. His articles have appeared in Bloomberg BNA’s Health Care Daily Report, Medicare Report and the Medical Devices Law & Industry Report.Read More
Justyna Zwolak, Ph. D
In addition to her doctorate in Physics from the Nicolaus Copernicus University in Poland, Dr Zwolak has a Master of Science degree in Mathematics and has developed her own software for statistical calculations and verifying statistical methodology for scientific trials.Read More
next. generation. advisors.
Goldbug Strategies LLC
510 Diamondback Drive, Suite 570
Gaithersburg, Maryland 20878
+1 (301) 355-2660