Manager IVD Rapid Test Manufacturing & Regulatory Compliance

ABOUT THE COMPANY

We are a well-established Medical Device Manufacturing company with over 20 years of industry experience, recognized for delivering high-quality healthcare solutions and maintaining strong compliance with global quality standards. As part of our strategic growth initiatives, we are expanding our portfolio into the In Vitro Diagnostics (IVD) segment, with a focus on innovative rapid diagnostic test solutions. This expansion presents an exciting opportunity for professionals to contribute to the development and commercialization of next-generation diagnostic products in a dynamic and growth-oriented environment.

ABOUT THE ROLE

We are seeking an experienced and dynamic manager to support the manufacturing of In Vitro Diagnostic (IVD) Rapid Tests while ensuring compliance with applicable regulatory and quality requirements. The ideal candidate will have hands-on experience in rapid diagnostic test manufacturing processes, quality systems, documentation practices, and regulatory compliance within the in-vitro diagnostics industry, including WHO Prequalification, EU MDR, and CDSCO requirements.

KEY RESPONSIBILITIES

1) Manufacturing Operations

• Execute and supervise manufacturing activities for IVD rapid test products, including reagent preparation, membrane coating, conjugation, assembly, cutting, pouching, and packaging. 

• Ensure adherence to approved manufacturing procedures, batch records, and work instructions. 

• Monitor production processes and maintain product quality, yield, and productivity targets. 

• Support process validation, equipment qualification, and manufacturing scale-up activities. 

• Investigate manufacturing deviations and implement corrective and preventive actions (CAPA). 

2) Regulatory & Quality Compliance

• Ensure compliance with applicable regulations and standards, including: 

o ISO 13485 

o Good Manufacturing Practices (GMP) 

o IVDR / IVD regulations (as applicable) 

o CDSCO Medical Device Rules (India) and related guidelines 

o EU MDR 

o ISO 13485 

o WHO Prequalification

• Maintain manufacturing and quality documentation in accordance with regulatory requirements. 

• Support internal audits, external audits, and regulatory inspections. 

• Participate in risk management, change control, non-conformance management, and CAPA activities. 

• Assist in preparation and review of technical documentation, device master records, and quality records. 

• Coordinate preparation, review, and submission of CDSCO dossiers and technical documentation. 

• Liaise with regulatory authorities, notified bodies, auditors, and certification agencies. 

• Ensure readiness for regulatory inspections and audits. 

3) Factory Setup & Commissioning

• Lead end-to-end setup of manufacturing facility including: 

o Plant layout planning 

o Utility planning 

o Equipment selection and qualification 

o Cleanroom & DH room setup 

o Validation and commissioning 

• Establish manufacturing processes, SOPs, workflows, and operational controls. 

• Coordinate with architects, consultants, EPC vendors, and engineering teams during project execution. 

• Factory team building

4) Manufacturing Operations

• Oversee daily manufacturing operations to ensure quality, productivity, and compliance of Rapid Diagnostic Tests, Agglutination Tests and Molecular Biology QRTPCR Tests. 

• Develop and implement production planning and capacity optimization strategies. 

• Drive continuous improvement initiatives in productivity, efficiency, and cost reduction. 

• Ensure adherence to GMP, EHS, and quality standards. 

• Monitor KPIs related to production, rejection rates, downtime, and operational efficiency. 

5) Documentation & Reporting

• Prepare and review Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), protocols and reports. 

• Ensure accurate documentation practices and data integrity. 

• Generate production and compliance reports for management review. 

6) Cross-Functional Collaboration

• Coordinate with Quality Assurance, Quality Control, R&D, Regulatory Affairs, and Supply Chain teams. 

• Support new product transfer from R&D to manufacturing. 

• Provide training to production personnel on GMP and regulatory requirements. 

REQUIRED QUALIFICATIONS

• Master's degree in Biotechnology, Microbiology, Biochemistry, Biomedical Engineering, DMLT, Life Sciences, or related field. 

• 5 to 7 years of experience in IVD rapid test manufacturing, medical devices, diagnostics, or regulated healthcare manufacturing.

• Proven experience & understanding of lateral flow assay (LFA) manufacturing process.

• Knowledge of ISO 13485, CDSCO regulations, WHO Prequalification, EU MDR 

• Experience in dossier preparation and regulatory submissions. 

• Strong understanding of manufacturing systems, validation, and quality compliance. 

• Experience handling audits, inspections, and quality documentation.

PREFERRED SKILLS

• Experience with technology transfer and process validation. 

• Understanding of Design Control and Product Lifecycle Management. 

• Strong problem-solving and root cause analysis skills. 

• Excellent documentation and communication abilities. 

• Proficiency in MS Office and quality management systems. 

KEY COMPETENCIES

• Regulatory Compliance 

• Quality Mindset 

• Attention to Detail 

• Process Improvement 

• Team Collaboration 

• Analytical Thinking 

• Documentation Excellence 

WHAT WE OFFER

• Competitive salary and benefits. 

• Opportunity to work in a growing diagnostics and healthcare environment. 

• Exposure to global quality and regulatory standards. 

• Career growth and professional development opportunities.