Senior Manager-Program Mgmt-Medical Devices

Sampoorna Computer People; Bengaluru; On-site; INR 3,000,000 - 5,500,000; Full time

Job summary

Sampoorna Computer People seeks a Senior Manager-Program Mgmt in Medical Devices to lead the diagnostics pipeline from feasibility to launch. You will manage timelines, milestones, risks, and resources across functions.

Key duties include driving design transfer for IVD kits, coordinating regulatory filings (CDSCO, CE-IVDR), and building external partnerships with hospitals, labs, and KOLs to support validations and studies. This is Bengaluru-based.

Qualifications

• Bachelor’s or higher in life sciences; Master’s/PhD preferred.
• 5-8 years in molecular diagnostics kit development (IVD) and launches in India and Europe (CDSCO/CE-IVD/IVDR).
• Project management experience running multi-stakeholder programs to deadline in diagnostics or life sciences.
• Working knowledge of clinical performance studies and ISO 13485 quality systems advantageous.

Responsibilities

• Own the diagnostics pipeline end-to-end—timelines, milestones, risks, and resources from feasibility to launch.
• Drive IVD kit design transfer, verification and validation, and regulatory filings (CDSCO, CE-IVDR).
• Build external partnerships with hospitals, labs, and KOLs to secure samples, run validations, demos, and studies.
• Design and manage performance studies—protocols, site coordination, data analysis, and reports.
• Coordinate across R&D, Manufacturing, QA/RA, and Commercial to clear bottlenecks and speed up decisions.
• Build dashboards on pipeline status, timelines, and cost; flag risks early.
• Run program reviews and prepare updates for leadership, partners, and funders.

Skills

Project management

Analytical skills

Stakeholder management

Partner-facing

PMP certification

ISO 13485 knowledge

Clinical performance studies

Education

Bachelor’s degree in life sciences/biotechnology/molecular biology

Master’s or PhD preferred

Job description

Senior Manager-Program Mgmt-Medical Devices - J50963

Role & responsibilities

Key Responsibilities

• Own the diagnostics pipeline end-to-endtimelines, milestones, risks, and resources from feasibility to launch.
• Drive IVD kits through design transfer, verification and validation, and regulatory filings (CDSCO, CE-IVDR).
• Build external partnerships with hospitals, labs, and KOLs to secure samples, run validations, demos, and studies.
• Design and manage performance studies—protocols, site coordination, data analysis, and reports.
• Coordinate across R&D, Manufacturing, QA/RA, and Commercial to clear bottlenecks and speed up decisions.
• Build dashboards on pipeline status, timelines, and cost; flag risks early.
• Run program reviews and prepare updates for leadership, partners, and funders.

Qualifications

• Science background (must have): Bachelor’s or above in life sciences, biotechnology, or molecular biology; Master’s or PhD preferred
• 5 - 8 years’ experience in molecular diagnostics kit development (IVD) and launch across Indian (CDSCO) and European (CE-IVD/IVDR) pathways is a MUST
• Project management experience running multi-stakeholder programs to deadline in diagnostics or life sciences is a MUST
• Working knowledge of clinical performance studies and ISO 13485 quality systems will be an added advantage
• Excellent analytical skills; comfortable with data, timelines, and trade-offs
• Confident in partner-facing roles; network with hospitals, labs, or CROs a plus
• PMP certification will be an added advantage