Affiliate Consultant Network
The Boudicca® DX affiliate consultant model is built on a simple principle: the best precision medicine experts shouldn’t have to choose between meaningful client work and the flexibility of independent practice.
Our affiliate consultants are active, credentialed professionals embedded in the precision medicine industry — regulatory affairs leads, translational scientists, quality systems experts, CDx co-development specialists, and laboratory directors who want to do their best work without the overhead of building a firm around it. Boudicca® DX handles business development and contracting.
What We Look For
We are selective by design. The precision medicine space moves fast and our clients trust us because every consultant we deploy can perform at the highest level from day one. Strong candidates typically bring:
Advanced credentials — PhD, MD, PharmD, or equivalent in a relevant discipline; professional certifications such as RAC-Devices, MB(ASCP), PRRC qualification, or ISO auditor credentials are a strong plus
Verifiable hands-on experience — direct, first-person experience with regulatory submissions, assay development and validation, quality audits, or CDx co-development — not advisory or managerial distance from the work
Regulatory depth in at least one major jurisdiction — US FDA (CDRH), EU IVDR/MDR, or a major ROW market such as PMDA, TGA, or MHRA; dual-jurisdiction expertise is highly valued
Active industry engagement — our consultants are current, not retired from the field; we look for professionals who are tracking guidance changes, attending scientific meetings, and producing work that reflects the present regulatory environment
Collaborative mindset — Boudicca® DX engagements often require rapid deployment, cross-functional coordination, and direct client-facing communication; consultants who operate well independently and within a team structure thrive here
Commitment to quality — all deliverables go through internal review before client delivery; consultants who welcome peer review and hold their own work to publication-level standards are a natural fit
Areas of Immediate Interest
We are actively expanding our affiliate network in the following areas:
- EU IVDR and MDR regulatory affairs (PRRC-qualified candidates strongly preferred)
- US FDA regulatory affairs — IVD and medical device submissions
- Clinical laboratory science — CLIA, CAP, NYS-CLEP, LDT development
- Biostatistics — GCP and GLP-compliant study design and SAP preparation
- Quality systems and compliance — ISO 13485, 21 CFR Part 820, BIMO/PAI experience
- Translational science and biomarker strategy
- Reimbursement strategy — MolDX, payer strategy, clinical utility study design
- SaMD and digital health regulatory affairs — IEC 62304, ISO 27001, AI/ML
If you are an experienced precision medicine professional interested in joining the Boudicca® DX affiliate network — or a program coordinator exploring internship opportunities — we’d like to hear from you.
Contact: courtney@boudiccadx.com
