Areas of Deep Expertise
Medical device success requires specialized talent across multiple disciplines. I’ve built deep expertise in the functional areas that drive regulatory approval, clinical validation, and commercial success.
Medical device success requires specialized talent across multiple disciplines. I’ve built deep expertise in the functional areas that drive regulatory approval, clinical validation, and commercial success.
The regulatory function is the linchpin of medical device companies. I recruit professionals who understand FDA pathways, prepare compelling submissions, interact effectively with regulators, and maintain compliance throughout the product lifecycle.
VP Regulatory Affairs, Director Regulatory Affairs, Regulatory Affairs Manager, Regulatory Specialists (510k, PMA, De Novo), International Regulatory Affairs
FDA submission expertise, regulatory strategy, agency interactions, global regulatory knowledge, risk assessment, pathway selection
Quality excellence protects patients and enables commercial success. I identify leaders who build robust quality management systems, manage audits and inspections, drive CAPA effectiveness, and establish cultures of quality.
VP Quality, Director Quality Assurance, Quality Manager, Quality Engineers, Compliance Specialists, Document Control Manager
QMS implementation, ISO 13485, FDA 21 CFR Part 820, audit management, CAPA, process validation, supplier quality
Clinical evidence drives regulatory approval and commercial adoption. I recruit professionals who design clinical strategies, execute trials, analyze data, and build the evidence foundation for product claims.
VP Clinical Affairs, Clinical Affairs Director, Clinical Research Manager, Clinical Specialists, Clinical Trial Managers, Biostatisticians
Clinical trial design, protocol development, IDE applications, data analysis, physician relationships, evidence generation strategy
Innovation pipelines fuel future growth. I identify technical leaders and engineers who conceive breakthrough devices, navigate design controls, solve complex problems, and deliver products that improve patient outcomes.
VP R&D, VP Engineering, Director Product Development, Senior Engineers (Mechanical, Electrical, Software), R&D Program Managers
Device design, design controls, V&V, design transfer, innovation management, technical problem-solving, cross-functional collaboration
Usability determines real-world device safety and effectiveness. I recruit specialists who conduct formative and summative testing, identify use-related risks, and ensure devices are intuitive and safe in clinical environments.
Director Human Factors, Human Factors Engineers, Usability Specialists, User Experience Researchers
HFE/UE testing, IEC 62366 compliance, use-related risk analysis, formative studies, summative validation, FDA human factors guidance
Clear, compelling regulatory documents accelerate approvals. I identify writers who translate complex technical and clinical information into submissions that satisfy FDA requirements and support approval decisions.
Regulatory Writers, Medical Writers, Technical Writers, Clinical Documentation Specialists
Regulatory document preparation, clinical evaluation reports, technical files, summary of safety and effectiveness, scientific writing, FDA format requirements
Technical excellence in device design and development is non-negotiable. I recruit engineers with deep expertise in relevant disciplines who understand both the engineering and regulatory requirements of medical device development.
Biomedical Engineers, Mechanical Engineers, Electrical Engineers, Software Engineers, Materials Engineers, Test Engineers
Device design, CAD, prototyping, testing protocols, materials selection, software development for medical devices, design documentation
Technical excellence in device design and development is non-negotiable. I recruit engineers with deep expertise in relevant disciplines who understand both the engineering and regulatory requirements of medical device development.
Complaint handling, MDR reporting, trend analysis, field actions, safety monitoring
Program management, stage-gate processes, cross-functional coordination, development timelines
Coverage strategy, coding, payment policy, health economics, payer engagement
Value propositions, health technology assessment, pricing strategy, commercialization planning
Manufacturing scale-up, supply chain management, process optimization, operational excellence
Specialized expertise in building high-performing teams for medical device innovation