Management of Document Control and QA Training staff. Develop and maintain device master records, device history records, design history files, change orders, deviations, quality system procedures and other documentation systems.
Maintains current industry Standard and Regulation records.
Manages Regulatory Training function. Establishes and manages the necessary training programs to ensure the Company complies with company procedures and applicable federal regulations and international standards.
Develops, implements, maintains andimproves regulatory training program to ensure compliance with regulatory and standard requirements related to its design, manufacturing, and distribution of medical devices, including the CFR Quality System Regulations per CFR Part 820 (cGMP) and ISO 13485 standard requirements PMDA in the CR site.
Overseesand work with Document Control and Training staff, and with another’s departments, to ensures the appropriate management and maintenance of records and documents.
Controls and manage the training and document controls electronic programs including its maintenance and validation processes.