Department: Quality & Compliance

Reporting To: Quality & Compliance Manager / Head – Quality & Compliance

Experience: 6 Months – 1 Year

Industry: Healthcare IT / Software

Job Purpose

Responsible for coordinating and maintaining Quality Management Systems, certifications, accreditations, regulatory compliance, legal documentation, audits, and Government/PPP tender activities for Medimaze.

Key Responsibilities
Maintain and update QMS documentation, SOPs, policies, records, and trackers.
Support and coordinate ISO, CMMI, CE/MDR, CDSCO, NABH HIMS/EMR, NABH RIS/PACS, HIPAA, US FDA and other certifications/accreditations.
Coordinate internal, external, surveillance, certification, regulatory, and customer audits.
Track NCs, CAPAs, observations, corrective actions, and closure timelines.
Maintain audit-ready documentation and compliance evidence.
Coordinate regulatory activities and maintain applicable regulatory/compliance trackers.
Coordinate legal agreements, renewals, licenses, statutory documents, and compliance requirements with internal teams and legal consultants.
Coordinate with Business Development, Finance, Legal, HR, IT, Product, and Technical teams for tender and compliance requirements.
Maintain certification, accreditation, audit, legal, tender,



renewal, and compliance trackers.
Prepare KPI, MIS, dashboards, and management reports.
Coordinate weekly quality/compliance meetings, prepare MOMs, and track action items.
Coordinate Management Review Meetings (MRM) and maintain action trackers.
Support quality and compliance training and awareness programs.
Support risk management, continuous improvement, and process compliance initiatives.
Ensure timely renewal of certifications, agreements, licenses, and other compliance requirements.
Support management in maintaining overall audit and compliance readiness.

Key Skills
QMS & Compliance Management
Audit & CAPA Coordination
Certification & Accreditation Management
Regulatory & Legal Coordination
Government/PPP Tender Coordination
Documentation & Record Management
MIS, Excel & Tracker Management
Robust Communication, Coordination & Follow-up
Healthcare IT / Medical Device Software compliance knowledge preferred

Preferred Experience 6 months – 1 yearof experience in Quality, Compliance, Regulatory Affairs, QMS, Healthcare IT, Medical Device Software, or Government Tender Management.

Work Location: In person

📌 Quality & Compliance Executive Pune
🏢 Medimaze Solutions
📍 Pune