Responsibilities: - Must have: FDA 510(k) - Plan, establish, and maintain a Quality Management System in accordance with EN ISO 13485 - Implement regulatory strategies for maintaining compliance with established standards like IEC 60601, IEC 62304, US FDA and CE Marking, etc. - Prepares dossiers and device master files for regulatory submissions - Follow the Medical Device Act by CDSCO and other relevant regulations related to products developed and provide directions for compliance to the organization. - Work with different teams to setup Quality policies and standards - Ensuring all established quality and delivery commitments are met such as working within FDA regulations, Design Control and ISO Standards. - Training and ensuring all assigned employees are aware of and comply with company policies, government procedures, and regulations. - Working closely with product development and product transfer teams. - Supplier Audit and Qualification. - Assist with Management Review meetings including generation of quality metrics and coordinating the review. - Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal procedures to assure compliance for QMS. - Lead audit and inspection preparation, resolution of audit, and inspection findings with relevant stakeholders through all stages of the audits. - Coordinate CAPA's meetings and provide assistance to the corrective action owners to ensure effectiveness. - Ensure employee training compliance to Corporate and site-level QMS. May be responsible for preparing and facilitating quality-related training programs for employees. Qualifications : - Minimum 4-5 years of experience in Medical Device Regulation. Experience with international medical device regulatory approvals and submissions - Experience supporting 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 - 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 the 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

Bangalore

Dozee - Regulatory Affairs Specialist 

Dozee - Regulatory Affairs Specialist  ,Job Description for Dozee - Regulatory Affairs Specialist  in Dozee in  Bangalore for (4-5) years of experience. Apply Now!

Job Description for Dozee - Regulatory Affairs Specialist  in Dozee in  Bangalore for (4-5) years of experience. Apply Now!