Careers

Support medical device companies in developing practical U.S. regulatory strategies, including product classification, pathway assessment, FDA submissions, and agency interactions. Consultants are engaged on a fractional, per-project basis based on relevant experience and client needs.

Support the development, implementation, and improvement of medical device quality management systems, including design controls, document control, risk management, CAPA, supplier controls, and audit readiness. Experience with FDA Quality System requirements, applicable ISO and international standards, and stage-appropriate QMS implementation is preferred.

Develop reimbursement and market access strategies for medical device start-ups, including coding, coverage, payment, evidence requirements, and payer or provider adoption. Consultants should be able to translate reimbursement considerations into practical clinical, regulatory, and commercialization recommendations.

Help medical device companies assess market opportunities, customer needs, competitive positioning, pricing, and go-to-market strategy. Consultants may support market research, stakeholder interviews, commercialization planning, and U.S. market-entry projects.

Advise medical device companies on intellectual property strategy, including patent landscape review, freedom-to-operate considerations, portfolio development, and filing or provisional patent applications. This role is suited to professionals who can connect IP decisions with product development, regulatory strategy, and commercialization objectives.