Job Description

As a QARA Manager, you will be responsible for maintaining the company's quality management system (QMS) that addresses FDA QSR, ISO13485, CE MDR and other international market medical device regulations/requirements. You will also be responsible for ensuring that products and their labeling meet all regulatory requirements (national and international).

Qualifications, Duties and Responsibilities:

• Establish, manage and maintain compliance with FDA QSR (GMP) (including company registration, new product submissions, establishing FDA communication/channels for compliance on medical device listings/classifications, management of CAPA system)
• Establish, manage and maintain compliance with the EU market MDR (including CE Mark applications or self-declarations via technical files)
• Establish, manage and maintain ISO 13485 requirements and certification
• Function as the Management Representative for the company. 
• Responsible for the customer complaint system and generating the monthly customer complaint report
• Responsible for evaluating product failures and generating the evaluation report
• Responsible for working with R&D and manufacturing to develop validation protocols for production processes, and generating the final report covering the validation results and a recommendation for approval or disapproval for the release of the process to manufacturing
• Conduct internal audits and coordinate/manage external ISO audit schedules, correspondence and closing of findings
• Ensure compliance of labeling and advertising requirements
• Maintain and audit design history files (DHF) for new products
• Responsible for the Documentation Control Process and Documentation Change Control Process

Education and Experience:

• A Bachelor of Science Degree with 5-10 years’ experience in Quality Assurance and Regulatory Affairs for software medical devices (SaMD) (MUST)
• Good grasp for the Software Development Life Cycle (SDLC) and related quality requirements (MUST)
• Experience with software verification and validation
• Performing internal audits
• Auditing vendor quality systems
• Writing standard operating procedures and work instructions
• Developing Management Control Systems