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.