Meet our regulatory and compliance experts

MDisrupt Regulatory and Compliance Experts

We are the experts in finding you health industry experts. The key to success in building healthtech products that scale is engaging healthcare experts early and often. Explore all available experts below. We can help.

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 Consultant

Experienced healthcare provider in medical consulting and device distribution. As a med device consultant, has collaborated executing business plans, marketing content creation, strategic planning, market intelligence, and technology assessments.

Key Skills:

      • Health Technology Assessments
      • Medical Affairs
      • Business Strategic Planning
      • Evidence Synthesis

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

Healthcare Regulatory Attorney and Compliance Expert

20+ years of experience as a healthcare attorney, Chief Privacy Officer, and Chief Compliance Officer: fraud & abuse, Corporate Integrity Agreements, and Sunshine Act reporting, defending payor audits, transactional matters.

Key Skills:

  • Significant reimbursement experience
  • Coverage policy issues
  • Obtaining HCPCS codes

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

Chief Medical Officer

Physician and biomedical engineer. Extensive expertise in healthtech, medical affairs, and product commercialization.  Founding team member for one of the largest consumer telemedicine platforms. Led clinical partnerships and diagnostic innovation for top microbiome company. Multi-state medical licensures.

Key Skills:

      • Microbiome Regulatory and Clinical Delivery
      • Telemedicine Implementation
      • Diagnostic Product Commercialization
      • Designing for User Engagement

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

Physician Innovator

Clinical Pathologist with subspecialty training in Molecular Genetics Pathology and Pathology Informatics, board-certified in Clinical Pathology, Molecular Genetics Pathology and Clinical Informatics with significant experience in digital imaging and telepathology, genomics and medical research. A particular focus on workflow analysis and process change, automation, improved human-computer interaction, and data analytics.

Key Skills:

  • Molecular Genetics Pathology
  • Clinical Informatics
  • Clinical Pathology
  • Health Information Systems and Analytics

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

Executive Physician Consultant

An experienced molecular pathologist with extensive executive experience in the genomics and biotech industry. Expertise ranges from test development, laboratory operations, medical affairs and medical/reimbursement strategy including being an accomplished communicator.

Key Skills:

  • Medical/Scientific Strategy
  • Evidence Development
  • Reimbursement Strategy
  • Genomic Medicine

Find Your Expert

Whether your company is early-stage or well-established, we connect you to the expertise you need to accelerate your health product’s path to market.

Medical

Commercial

Legal and Health Policy

Scientific

Market Access and Reimbursment

Regulatory and Compliance

Lab Operations

Join Us! Become an MDisruptor.

At MDisrupt, we match practicing health professionals to healthtech companies seeking to build clinically and commercially viable products. We handle the details, allowing you to do what you do best.

Regulatory and Compliance Experts 1

Experts Needed

  • Physicians
  • Scientists
  • Regulatory Experts
  • Health Economists
  • Lab Test Designers
  • Market Access Experts
  • Commercial Strategist
  • Clinical Trial Designers
Regulatory and Compliance Experts 2

Opportunities

  • Expert in Residence
  • Strategic Advisor
  • Key Opinion Leadership
  • Advisory Boards
  • Focus Groups
  • Consulting Projects
Become an MDisruptor

Check out our blog

How Healthtech Companies Can Avoid “Death by Pilot” When Working With Health Systems

How Healthtech Companies Can Avoid “Death by Pilot” When Working With Health Systems

Collaborations between healthtech startups and healthcare systems are being announced left and right these days. As you embark on the customer journey, you will undoubtedly be asked about the value your product or service adds and, most relevant to this conversation, whether there is a role for a pilot project in demonstrating the value you bring to a health system. Is a pilot just a hoop to jump through on the way to a sae—or can a pilot be a key tool in your mission to bring value to your customers?

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