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Designation: Head of Quality/ Regulatory (IVD)
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No of requirements: 01 Nos
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Department/Function:
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Quality
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Location:
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Mombasa- Kenya
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Reporting to (Name & Designation):
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Mr. Ankur Vora (Director)
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No of reportees:
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10-15 Nos
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Roles & responsibilities:
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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:
- ISO 13485, ISO 9001, ISO 14001
- MDSAP requirements
- 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:
- CE-IVD / IVDR requirements
- Country-specific regulations including:
- Kenya (PPB)
- South Africa (SAHPRA)
- 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
- Performance characteristics (sensitivity, specificity, stability)
- Oversee quality control systems across:
- Incoming materials (membranes, antibodies, reagents)
- In-process controls (coating, striping, assembly)
- Finished product testing
4. Audit & Certification Management
- Lead and manage:
- Internal audits
- External audits (ISO, MDSAP, notified bodies)
- 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:
- Design & development
- Manufacturing
- 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
- 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
- Data-driven quality metrics
8. Documentation & Change Control
- Ensure robust systems for:
- Document control (SOPs, specifications, records)
- Change control (engineering, process, material changes)
- Maintain audit-ready documentation including DMR, DHR, and technical files etc.
9. Training & Quality Culture
- Build and sustain a quality-first culture across the organization
- Ensure all employees are trained on:
- QMS procedures
- Regulatory requirements
- GMP practices
- Drive accountability and awareness at all levels
10. Customer Feedback & Post-Market Surveillance
- Manage:
- Customer complaints and investigations
- Adverse event reporting (vigilance)
- 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
- Supply Chain
- Support product lifecycle management from development to commercialization
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Minimum education qualification:
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· Bachelor’s Degree (mandatory) in one of the following disciplines:
- Biotechnology
- Biochemistry
- Biomedical Engineering
· Master’s Degree (preferred but not mandatory) in:
- Life Sciences / Biomedical Sciences
- Quality Management
- Regulatory Affairs
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Preferrable educational qualification:
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Any from Above
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Total experience required:
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· Typically, 10–15+ years in IVD QA & RA
· Strong exposure to regulatory audits, PQS for IVD
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Total relevant experience required:
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10 Year +
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Skills required:
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· Deep understanding of QMS & compliance
· Experience handling audits and certifications
· Strong leadership and decision-making ability
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Essential criterions for selection:
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· 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)
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Desirable but not essential criterions for selection:
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• Advanced Qualifications
- Master’s degree in:
- Regulatory Affairs / Quality Management
- Biomedical Sciences / Biotechnology
- 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)
- 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
- Dossier preparation for WHO Prequalification (PQ) (highly desirable)
• Advanced Risk Management Expertise
- Strong practical application of risk management as per ISO 14971
- Experience in:
- Risk analysis (FMEA, hazard analysis)
- Benefit-risk evaluation for IVD products
- 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)
- 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
- Commercial / Market Access teams
• African Market Regulatory Expertise (If Possible)
- Working knowledge of regulatory frameworks across African markets, including:
- Kenya (PPB)
- South Africa (SAHPRA)
- Uganda (NDA)
- Other emerging regulatory bodies
- Experience navigating multi-country approvals and compliance strategies
• IVD-Specific Technical Expertise (Strong Advantage)
- Experience with rapid diagnostic tests (RDTs) / lateral flow assays
- Understanding of:
- Sensitivity, specificity, and diagnostic performance validation
- Stability studies and shelf-life determination
- Biological materials (antibodies, antigens, reagents)
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Preferred age group:
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35 to 40 Years
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Target industries/companies:
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Only IVD manufacturing company
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Annual CTC:
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As per candidate ability
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Other perks/allowances:
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Travel, lunch during office time. Local medical & transport
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USP to attract best of the talent (why should the best candidate join us):
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1. Purpose with Real Impact
To Join a company that is directly improving healthcare access across Africa by manufacturing life-saving medical devices. Your work will impact millions of patients, mothers, and children across underserved markets.
2. One of Africa’s Leading Medical Device Manufacturers
Be part of a fast-growing, globally compliant manufacturing organization operating with ISO 13485, ISO 9001, ISO 14001, CE marking, and MDSAP standards, competing at international quality levels from an African base.
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Tentative date of onboarding:
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June 2026
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Buyout the notice period
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NO
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