Description

Microhaem Scientifics is a pioneering medical diagnostics manufacturer dedicated to advancing health equity across Africa and globally through high-quality, innovative in vitro diagnostics (IVDs). We operate in a fast-paced, stringently regulated environment, delivering cutting-edge point-of-care (POC) and molecular diagnostic solutions.

JOB PURPOSE:

We are seeking an exceptional, high-accountability R&D Director to lead our technical research, design execution, and product development strategy. The R&D Director will serve as the Subject Matter Expert (SME) across our entire medical device and IVD portfolio—driving end-to-end product development, design controls, risk management, and verification & validation (V&V) activities from concept to commercialization.

DUTIES AND RESPONSIBILITIES:

Essential functions of the position include but are not limited to the following. Other duties may be assigned.

Technical R&D & Product Development Leadership

• Lead end-to-end IVD product development (rapid diagnostic tests, real-time PCR, isothermal assays) in compliance with WHO Prequalification, ISO 13485, ISO 14971, and relevant Stringent Regulatory Authority (SRA) standards.
• Translate complex user and clinical needs into executable system specifications, development roadmaps, and risk mitigation strategies.
• Drive system architecture, hardware/software integration, reagent formulation, and analytical validation.
• Direct design transfer activities to commercial manufacturing, ensuring seamless scale-up and supplier integration.
• Lead root-cause investigations, technical troubleshooting, and continuous improvement for commercialized products.

Cross-Functional Integration & Regulatory Strategy

• Support compilation of technical documentation for regulatory submissions (WHO, NDA, CE-IVD, US FDA) in close partnership with Quality and Regulatory Affairs.
• Enforce rigorous Design History Files (DHF) and change control protocols.
• Support marketing and commercialization by generating technical application data, white papers, and presenting at international academic and industry symposia.

Team Leadership & Talent Culture

• Build, mentor, and direct a world-class R&D team committed to technical rigor, execution speed, and high accountability.
• Coordinate internal scientific teams and manage relationships with external international technical partners and research institutions.

QUALIFICATIONS & EXPERIENCE

Required Educational Background & Experience

• D. in Molecular Biology, Biotechnology, Biochemistry, Biomedical Engineering, or a closely related field, with at least 5 years of direct industrial experience developing IVD products/technologies.
• OR
• Master’s Degree in Molecular Biology, Biotechnology, Biomedical Engineering, or a related field, with at least 10+ years of direct industrial experience developing IVD products/technologies.

Technical & Regulatory Competencies

• Deep, hands-on expertise in developing point-of-care assays (lateral flow/immunoassays) and molecular diagnostic platforms (PCR, qPCR, nucleic acid extraction).
• Proven track record operating within medical device startups or commercial IVD manufacturing environments.
• In-depth mastery of ISO 13485, ISO 14971, IEC standards, WHO Prequalification guidelines, and SRA regulatory framework executions.
• High-level proficiency in modern technical software, eQMS platforms, statistical analysis tools, and technical project management frameworks.

Personal Attributes

• Entrepreneurial, builder mindset with strong systems-thinking and problem-solving abilities.
• Exceptional cross-cultural communication, leadership, and stakeholder management skills.
• Willingness to relocate to Kampala, Uganda

REMUNERATION & INTERNATIONAL RELOCATION PACKAGE

Comprehensive Compensation Package

• Base Salary: $60,000 – $84,000 USD Net per annum (Competitive salary based on education background and relevant experience).
• Housing: Full accommodation provided by the company.
• Transportation: Dedicated company transport provided.
• Medical insurance for staff and dependents
• Retirement/NSSF contributions
• Relocation Support: Relocation assistance and work permit sponsorship provided for eligible international candidates.

• Lead end-to-end IVD product development (rapid diagnostic tests, real-time PCR, isothermal assays) in compliance with WHO Prequalification, ISO 13485, ISO 14971, and relevant Stringent Regulatory Authority (SRA) standards.
• Translate complex user and clinical needs into executable system specifications, development roadmaps, and risk mitigation strategies.
• Drive system architecture, hardware/software integration, reagent formulation, and analytical validation.
• Direct design transfer activities to commercial manufacturing, ensuring seamless scale-up and supplier integration.
• Lead root-cause investigations, technical troubleshooting, and continuous improvement for commercialized products.
• Support compilation of technical documentation for regulatory submissions (WHO, NDA, CE-IVD, US FDA) in close partnership with Quality and Regulatory Affairs.
• Enforce rigorous Design History Files (DHF) and change control protocols.
• Support marketing and commercialization by generating technical application data, white papers, and presenting at international academic and industry symposia.
• Build, mentor, and direct a world-class R&D team committed to technical rigor, execution speed, and high accountability.
• Coordinate internal scientific teams and manage relationships with external international technical partners and research institutions.

• Deep, hands-on expertise in developing point-of-care assays (lateral flow/immunoassays) and molecular diagnostic platforms (PCR, qPCR, nucleic acid extraction).
• Proven track record operating within medical device startups or commercial IVD manufacturing environments.
• In-depth mastery of ISO 13485, ISO 14971, IEC standards, WHO Prequalification guidelines, and SRA regulatory framework executions.
• High-level proficiency in modern technical software, eQMS platforms, statistical analysis tools, and technical project management frameworks.
• Entrepreneurial, builder mindset with strong systems-thinking and problem-solving abilities.
• Exceptional cross-cultural communication, leadership, and stakeholder management skills.

• PhD in Molecular Biology, Biotechnology, Biochemistry, Biomedical Engineering, or a closely related field, with at least 5 years of direct industrial experience developing IVD products/technologies.
• OR Master’s Degree in Molecular Biology, Biotechnology, Biomedical Engineering, or a related field, with at least 10+ years of direct industrial experience developing IVD products/technologies.