Senior Manager, On-Market Substainment

Manage On-Market Sustainment activities for the Indian Development Center (IDC), including Technical Publications and IVDR transition tasks.

Oversee IVDR transition deliverables and maintain compliance documentation.

Monitor and ensure adherence to FDA regulations, EU IVDR requirements, and other global regulatory standards.

Maintain audit-ready regulatory compliance records and update repositories per global requirements.

Coordinate regulatory submission documents for Market Expansion and Market Protection activities.

Support cross-functional regulatory readiness, including systems, documentation, and training platforms.

Ensure alignment of all on-market product activities with internal quality system procedures.