Senior Manager - Program Management - Medical Devices

Key Responsibilities:

- Own the diagnostics pipeline end - to - end - timelines, 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.