Gulmohar Health Care Private Limited
Website:
gulmoharhealthcare.com
Job details:
About the Role
Gulmohar Health Care Pvt. Ltd. is looking for an experienced and proactive Production & Regulatory Affairs Manager to oversee manufacturing operations, quality management systems, regulatory compliance, and medical device licensing activities.
The ideal candidate will be responsible for ensuring efficient production processes while managing ISO 13485 compliance, CDSCO documentation, product registrations, and end-to-end licensing procedures required for medical device approvals and market authorization.
Key Responsibilities
Production Management
• Plan, organize, and supervise daily production activities.
• Ensure production targets are achieved while maintaining quality standards.
• Monitor manpower utilization, productivity, and process efficiency.
• Coordinate with procurement, warehouse, quality, and service departments.
• Maintain production records, reports, and manufacturing documentation.
• Implement process improvements to enhance operational efficiency.
Regulatory Affairs & Licensing
• Manage end-to-end regulatory documentation for medical devices.
• Handle CDSCO submissions, approvals, renewals, and regulatory compliance activities.
• Coordinate and manage all activities related to obtaining new licenses, registrations, and product authorizations.
• Ensure timely completion and submission of documents required for regulatory approvals.
• Liaise with consultants, certification bodies, and regulatory authorities.
• Monitor regulatory changes and ensure organizational compliance.
Quality Management System (QMS)
• Implement, maintain, and improve the Quality Management System as per ISO 13485 requirements.
• Maintain and control QMS documentation, including SOPs, DHR, DMR, BOM, CAPA, calibration records, traceability records, and validation documents.
• Conduct internal audits and coordinate external audits.
• Ensure audit readiness and closure of non-conformities.
• Support continuous improvement initiatives and quality objectives.
Required Skills & Experience
- 3+ years of experience in Medical Device or Healthcare Equipment Industry.
- Strong understanding of ISO 13485 and Quality Management Systems.
- Experience in CDSCO regulations, licensing procedures, and regulatory documentation.
- Knowledge of medical device manufacturing processes and production planning.
- Experience handling audits, compliance requirements, and documentation control.
- Strong leadership, communication, and problem-solving skills.
- Ability to coordinate with multiple stakeholders and regulatory authorities.
Preferred Qualification
• B.Tech / B.E. / B.Pharm / M.Pharm / Biomedical Engineering / Life Sciences or related field.
• Experience with products such as Ventilators, Patient Monitors, BiPAP, CPAP, or other medical devices will be preferred.
Employee Benefits
✅ Paid Leaves
✅ Health Insurance
✅ Mobile Reimbursement
✅ Positive & Professional Work Environment
✅ Career Growth Opportunities
Click on Apply to know more.