Regulatory Engineer

Work Location: Hyderabad/Hybrid

• Experience: - 3+
• Include dossier preparation, on-time tracking of applications and network with regulatory bodies and bring in compliance.
• Play an active role in a change environment
• Supports the ongoing implementation and sustainment of Quality and Regulatory compliance as per local and international rules and regulations.
• Minimum 3-5 years of experience in Medical Device Regulation. Experience with international medical device regulatory approvals and submissions
• Awareness of regulatory agency inspections and Notified Body Audits in an SME role
• Demonstrated knowledge of US FDA, EU MDR, ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices as well as IEC 62304, IEC60601etc.
• Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents
• Proven experience in new medical device registrations and filings
• Working experience with CDSCO, Notified body and other associations for medical device regulation
• Able to constructively collaborate with cross-functional teams
• Working knowledge of quality assurance methodologies
• Knowledge of commonly used concepts, practices, and procedures for a full product development life-cycle and Medical Device Quality Management System.
• Support compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained.
• Providing guidance to the team to interpret regulatory requirements for various life-cycle stages of the project
• Drive Good Documentation practices
• Ability to follow instructions, work independently, or function in a team as needed
• Highly organized, process orientated and adherence to standard process.
• Exhibit good leadership across departments and teams.
• Good time management and project management.
• Collaborative and a team player
• Good interpersonal, listening and communication skill.