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