Role Overview:

As the Head of Quality and Regulatory for our IVD division, you will serve as the primary architect of our compliance framework, ensuring that our diagnostic products meet the highest global safety and efficacy standards. You will lead the strategic alignment between Quality Assurance, Regulatory Affairs, and product development teams to navigate complex international regulatory landscapes. By fostering a culture of quality, you will directly influence our market access strategy, mitigate operational risks, and ensure that our life-saving diagnostic solutions reach healthcare providers and patients with uncompromising integrity. This role demands a leader who can bridge the gap between technical precision and commercial objectives, working closely with cross-functional stakeholders to uphold our reputation for excellence in the medical device sector.

1. Quality Management System (QMS) Leadership:

- Hands-on exposure to WHO Prequalification (PQ) processes, audits, and documentation

- Establish, implement, and continuously improve an integrated QMS aligned with:

1. ISO 13485, ISO 9001, ISO 14001

2. MDSAP requirements

3. Applicable African regulatory frameworks

- Ensure QMS effectiveness across IVD manufacturing, R&D, and supply chain functions

2. Regulatory Compliance (IVD Focus):

- Hands-on exposure to WHO Prequalification (PQ) processes, audits, and documentation

- Ensure compliance with:

1. CE-IVD / IVDR requirements

2. Country-specific regulations including Kenya (PPB), South Africa (SAHPRA), and Uganda (NDA)

- Support product registrations and regulatory submissions across African and international markets

- Act as the primary quality interface with regulatory authorities and notified bodies

3. Product Quality & Patient Safety:

- Ensure all IVD products (Malaria, HIV, Pregnancy rapid tests, etc.) meet defined quality specifications and performance characteristics (sensitivity, specificity, stability)

- Oversee quality control systems across incoming materials (membranes, antibodies, reagents), in-process controls (coating, striping, assembly), and finished product testing

4. Audit & Certification Management:

- Lead and manage internal audits, external audits (ISO, MDSAP, notified bodies), and regulatory inspections and WHO PQ audits

- Ensure timely closure of audit findings with robust CAPA

- Maintain all certifications and ensure ongoing compliance readiness

5. Risk Management (ISO 14971):

- Implement and maintain risk management processes throughout product lifecycle including design & development, manufacturing, and post-market phase

- Ensure risk files (FMEA, hazard analysis) are complete and updated

6. Supplier & Manufacturing Quality:

- Establish supplier qualification, approval, and monitoring systems

- Ensure GMP compliance across manufacturing operations

- Drive robust quality assurance across incoming inspection, in-process checks, and final release

7. CAPA & Continuous Improvement:

- Lead Corrective and Preventive Action (CAPA) system

- Ensure effective root cause analysis (RCA) and timely closure

- Drive continuous improvement initiatives using Lean / Six Sigma methodologies and data-driven quality metrics

8. Documentation & Change Control:

- Ensure robust systems for document control (SOPs, specifications, records) and change control (engineering, process, material changes)

- Maintain audit-ready documentation including DMR, DHR, and technical files

9. Training & Quality Culture:

- Build and sustain a quality-first culture across the organization

- Ensure all employees are trained on QMS procedures, regulatory requirements, and GMP practices

- Drive accountability and awareness at all levels

10. Customer Feedback & Post-Market Surveillance:

- Manage customer complaints and investigations, adverse event reporting (vigilance), and Field Safety Corrective Actions (FSCA)

- Ensure effective post-market surveillance systems for IVD products

11. Sustainability & EHS Compliance:

- Ensure compliance with ISO 14001 (Environmental Management System)

- Promote safe handling of biological and chemical materials

- Drive workplace safety and sustainability initiatives

12. Cross-Functional Leadership:

- Collaborate closely with Manufacturing, R&D / Product Development, Regulatory Affairs, and Supply Chain

- Support product lifecycle management from development to commercialization

Key Responsibilities:

- Direct the end-to-end regulatory strategy for IVD product registrations, ensuring timely market entry and compliance with evolving global health authority requirements.

- Oversee the Quality Management System (QMS) to ensure seamless adherence to ISO 13485 and other relevant international standards, driving continuous improvement across all manufacturing and testing processes.

- Lead internal and external audit programs, acting as the primary liaison for regulatory bodies and notified bodies to maintain our license to operate.

- Manage the Clinical Quality Assurance function to ensure that all clinical evaluation data is robust, accurate, and fully compliant with regulatory submission standards.

- Mentor and develop a high-performing quality team, fostering a proactive mindset that prioritizes risk management and product safety throughout the entire product lifecycle.

- Collaborate with R&D and supply chain teams to integrate quality-by-design principles, reducing time-to-market while maintaining rigorous control over product quality and regulatory documentation.

Required Skillset:

- Typically, 1015+ years in IVD QA & RA

- Strong exposure to regulatory audits and PQS for IVD

- Deep understanding of QMS & compliance

- Experience handling audits and certifications

- Strong leadership and decision-making ability

- ISO 13485 Lead Auditor / Internal Auditor

- ISO 9001 & ISO 14001 Auditor certifications

- Training in ISO 14971 (Risk Management)

- MDSAP awareness or auditor certification

- GMP (Good Manufacturing Practices)

- Advanced Qualifications: Masters degree in Regulatory Affairs / Quality Management, Biomedical Sciences / Biotechnology, or Engineering (Biomedical, Chemical, or related)

- International Regulatory Exposure (IVD Specific): Hands-on experience with global regulatory frameworks such as US FDA (21 CFR Part 820 / QSR), EU IVDR (In Vitro Diagnostic Regulation), and UKCA (UK Medical Device Regulations)

- Experience aligning IVD products with global market entry requirements alongside ISO, CE, and MDSAP

- Regulatory Submission & Technical Documentation: Proven experience in CE-IVD / IVDR technical documentation (Technical File / Design Dossier), product registrations across multiple geographies, and dossier preparation for WHO Prequalification (PQ) (highly desirable)

- Advanced Risk Management Expertise: Strong practical application of risk management as per ISO 14971 including risk analysis (FMEA, hazard analysis), benefit-risk evaluation for IVD products, and integration of risk management into design, manufacturing, and post-market stages

- New Product Introduction (NPI) & Design Control: Experience in design control processes (design inputs/outputs, verification & validation), process validation (IQ/OQ/PQ), and technology transfer from R&D to manufacturing for IVD (lateral flow assays preferred)

- Cross-Functional Leadership Exposure: Demonstrated ability to work in a matrix organization, collaborating with R&D / Product Development, Manufacturing / Operations, Supply Chain & Procurement, and Commercial / Market Access teams

- African Market Regulatory Expertise: Working knowledge of regulatory frameworks across African markets, including Kenya (PPB), South Africa (SAHPRA), Uganda (NDA), and other emerging regulatory bodies

- Experience navigating multi-country approvals and compliance strategies

- IVD-Specific Technical Expertise: Experience with rapid diagnostic tests (RDTs) / lateral flow assays and understanding of sensitivity, specificity, and diagnostic performance validation, stability studies and shelf-life determination, and biological materials (antibodies, antigens, reagents)