Head of Product Development - IVD

ARC Regulatory is seeking a dynamic Head of Product Development - IVD to lead the transition of diagnostic products from Research Use Only (RUO) to Investigational Use Only (IUO). This senior role offers the opportunity to shape product strategy, drive assay development, and manage cross-functional initiatives with Regulatory, Clinical, QA, and Lab teams.

Key Responsibilities

Lead end-to-end IVD development from RUO to IUO.

Define product roadmaps and oversee assay design, validation, and tech transfer.

Ensure compliance with ISO 13485, FDA 21 CFR Part 820, IVDR, and ISO 14971.

Inspire cross-functional teams and collaborate with internal and external stakeholders.

Oversee project timelines, budgets, and regulatory readiness for clinical trials.

Qualifications

PhD/MSc in Biological Sciences or related field.

5+ years in IVD or life sciences product development.

Proven experience in regulatory and clinical readiness for IVD products.

Strong knowledge of design control, quality systems, and assay validation.

Preferred

Experience with companion diagnostics or LDT strategies.

Familiarity with digital health or SaMD.