Quality and Regulatory Manager

• Sep 2022 - Present

Current Responsibilities o Establishing and/or reviewing quality procedures and other quality documents and records as per requirements of medical device governing standards and regulations (21 CFR Part 11, Part 820, ISO 13485, EU Medical Device Regulation) to ensure capability and compliance. o To ensure proper application of applicable procedures o Working with engineers from the development team to prepare technical documentation in compliance with country specific regulations. (CE and FDA) o Performing regular regulatory monitoring, impact analysis of new standards o Facilitating submission of Regulatory documentation (CE and FDA) o Managing, scheduling, executing, and following the internal audits process as appropriate. o Supporting external audits/inspections. o Managing the Document Control process as part of the Quality Management System. o Promoting continuous improvement o Maintaining, performing, and following the Onward training system, coordinate document acknowledgement and training activities o Ensureing corrective or preventive actions are taken to address quality related problems. (Complaints, device deficiencies. Nonconformities).