Location: Dubai
A well-funded, fast-growing digital diagnostics company is seeking a Program Manager Digital IVD to lead end-to-end product development across a portfolio of connected in-vitro diagnostic devices.
The role spans products integrating lateral flow chemistry, compact imaging systems, and AI/ML-driven interpretation, and requires strong ownership of design controls, regulatory execution, and cross-functional delivery across biotech, software, and hardware teams.
This is a highly visible role with direct influence on product strategy, execution, and regulatory readiness.
Core Responsibilities
- Lead cross-functional engineering teams to translate lab-stage prototypes into scalable, real-world home diagnostic products.
- Own Design Control execution across multiple Digital IVD programs, ensuring compliance with ISO 13485 and 21 CFR 820.30.
- Translate clinical and market needs into clear MRDs and PRDs, maintaining full traceability through verification and validation.
- Plan and oversee execution across distributed teams covering biotech, software/AI, and mechanical/packaging development.
- Run sprint-based development within a regulated design control framework - maintaining velocity without compromising compliance.
- Drive risk management activities including DFMEAs, and ensure high-quality Design History Files (DHFs).
- Track cost, schedule, and risk across programs, ensuring readiness for clinical, regulatory, and manufacturing milestones.
- Guide development of both hardware-integrated and smartphone-based Digital IVD platforms.
Technical & Leadership Scope
- Partner closely with assay and reagent teams to ensure analytical performance consistency from R&D through manufacturing scale-up.
- Work with AI and data science teams to ensure model development aligns with Good Machine Learning Practices (GMLP) and SaMD regulatory expectations.
- Oversee software development aligned with SDLC and SaMD documentation standards.
- Drive design for manufacturability and usability across mechanical and packaging development.
- Support preparation for FDA and CE-IVDR submissions, and post-market activities where required.
Expected Outcomes
- Successful delivery of Digital IVD programs meeting analytical, usability, and regulatory performance goals.
- Predictable execution across assay, hardware, software, AI, and manufacturing streams.
- Audit-ready Design History Files across programs.
- Establishment of a repeatable program execution framework to support future diagnostic launches.
Candidate Profile
- 5+ years experience managing regulated product development (IVD, medical devices, or SaMD).
- Strong working knowledge of design controls, risk management, and regulatory submissions.
- Technical fluency across diagnostics, lateral flow systems, imaging-based assays, or connected medical devices.
- Proven experience leading multi-site, cross-disciplinary R&D teams.
- Comfortable operating in a fast-paced, startup environment with high ownership and limited hierarchy.
