MDisrupt Regulatory and Compliance Experts

Regulatory Affairs Strategist

Regulatory affairs expert who has advised healthtech companies across a range of regulatory affairs and health policy topics. Passionate about identifying strategic regulatory affairs pathways for LDTs, medical devices, and SaMD solutions.

Key Skills:

• Medical Device Regulatory Affairs
• Commercialization Compliance Requirements
• Product Development Protocol Processes

Chief Medical Officer

As an internist and endocrinologist, passionate about the potential for digital health solutions to improve access to care and the quality of healthcare delivery. Over 5 years experience at the FDA, focused on digital health and medical device regulation.

Key Skills:

• Digital Health
• Medical Devices
• Clinical Assessment
• Regulatory Policy

Medical Device Regulatory Expert

Medical device regulatory professional with 12+ years of experience in minimally-invasive surgical devices, orthopedic implants, digital health, patient monitoring, and neurodiagnostics. Specializing in device regulatory pathway development, design control, and software regulation for new product introduction activities.

Key Skills:

• Medical Device Software
• Design Control
• New Product Introduction
• Regulatory Pathway Development

Regulatory Affairs Stretegist

30+ years medical device regulatory veteran. Biomedical engineer with deep experience in digital health, orthopedic, otic, ophthalmic, cardiac, cardiovascular implant, catheter delivery, and minimally invasive surgery fields. Effective in developing strategy and relationships with regulators and securing and maintaining global approvals. Strong business acumen.

Key Skills:

• Regulatory Affairs
• Cardiovascular Implants
• US and EU Regulations

Policy & Engagement Strategist

Seasoned leader with successful track record designing and implementing new initiatives within complex systems. Expertise navigating the intersection of ethics and regulatory issues with precision medicine research and development, including internal and external stakeholder engagement and education.

Key Skills:

• Health Policy Analysis
• Internal and External Affairs Liaison
• Consent Issues
• Data Governance

Chief Medical Officer

30+ yrs experience in molecular diagnostics in regional and academic medical centers, biotech startups, and the reference lab settings. Expertise extends beyond molecular diagnostics to regulatory affairs and strategic considerations.

Key Skills:

• Molecular Diagnostics
• Regulatory Affairs
• Health Policy Trends Insights

Biotechnology Professional

Biomedical science professional with expertise in microbiology, microbiome science, and clinical research. Proven strong interpersonal and relationship management skills developed through experience in partnership management in academia and industry.

Key Skills:

• Clinical Research
• Scientific and Medical Affairs
• Evidence Synthesis
• Scientific Writing and Communication

Physician Innovator

Experienced physician working with numerous digital health companies developing products, advancing clinical use cases, developing quality data warehouses, and supporting funding rounds to get the best products to market.

Key Skills:

• Clinical Data Use Case Development
• Data Warehousing and Data Harmonization
• Designing for User Engagement
• Internal and External Affairs Liaison

Commercial Strategist

Precision Medicine Solutions Architect with 12+ years of health system experience and cradle-to-crave genomic test integration; successfully implemented a $10.5 million clinical precision medicine program; integrated nation’s first clinical pharmacogenomics panel for newborns.

Key Skills:

• Product Assessment
• Health System Integration
• Pharmacogenomics (PGx)

Laboratory Business Consultant

Dynamic leader skilled planning, developing, and implementing organizational and operational capability within early stage biotech companies. Demonstrated ability across diverse scientific, business, and investor stakeholders. Expertise establishing clinical laboratories, across genomic, pharmacogenomic, and “multi-omic” domains.

Key Skills:

• Laboratory Operations
• Product Management
• Regulatory Compliance
• Genetic Testing