Senior Manager, On-Market Substainment

Manage on-market sustainment activities for the Indian Development Center (IDC), including Technical Publications and IVDR transition activities.

Oversee execution of IVDR transition deliverables and maintain documentation required for ongoing compliance.

Monitor and verify adherence to FDA regulations, EU IVDR requirements, and applicable global regulatory standards.

Maintain audit-ready regulatory documentation repositories and ensure alignment with internal quality system procedures.

Coordinate collection, assembly, and version control of regulatory submission documents supporting market expansion and protection.

Execute cross-functional regulatory readiness activities to ensure systems, controlled documentation, and training platforms meet audit and inspection requirements.