Regulatory Affairs Specialist

Responsibilities

• 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. Turtle Shell Technologies Private Limited No. 40, City Centre, Chinmaya Mission Hospital Road, Bengaluru (Bangalore) Urban, Karnataka - 560038
• 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.

Requirements

• Educational Qualification- B.Tech
• Minimum 3-5 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 standard process.
• Exhibit good leadership across departments and teams.
• Good time management and project management.
• Collaborative and a team player, with good interpersonal, listening and communication skills