Medical Device Regulation Specialist
2 days ago
We are seeking an experienced Medical Device Regulation Specialist to join our team at Dozee, a leading AI-based contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS) company. This role is responsible for ensuring compliance with regulatory requirements, developing and implementing quality management systems, and providing expertise in interpreting policies and regulations.
About DozeeDozee is India's leading AI-based contactless RPM and EWS solution, continuously monitoring patients and providing early warnings of clinical deterioration, enabling timely interventions and enhancing patient safety in hospitals, nursing facilities, and patient homes. Our innovative technology has pioneered the world's first non-contact blood pressure monitoring system and has been trusted by leading healthcare providers in India, the USA, and Africa.
Responsibilities- Develop and implement quality management systems in accordance with EN ISO 13485
- Ensure compliance with established standards like IEC 60601, IEC 62304, US FDA, and CE Marking
- Prepare dossiers and device master files for regulatory submissions
- Work closely with different teams to set up Quality policies and standards
- Train and ensure all assigned employees are aware of and comply with company policies, government procedures, and regulations
- Lead audit and inspection preparation, resolution of audit and inspection findings, and coordinate CAPA's meetings
- B.Tech degree in a relevant field
- Minimum 3-5 years of experience in Medical Device Regulation
- Experience with international medical device regulatory approvals and submissions
- Demonstrated knowledge of US FDA, EU MDR, ISO 13485 Quality Management System, and ISO 14971 Risk Management for Medical Devices
As a Medical Device Regulation Specialist at Dozee, you will have the opportunity to work on cutting-edge technology that is transforming patient care. You will be part of a dynamic team that values innovation, collaboration, and continuous learning. In addition to a competitive salary of ₹25 lakhs - ₹30 lakhs per annum, you will also enjoy a range of benefits, including:
- A comprehensive health insurance plan
- A retirement savings plan
- Professional development opportunities
- A flexible work environment
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