QARA manager

Job Description: The QARA Manager is responsible for ensuring that the company’s products meet all regulatory requirements and quality standards. Work closely with all cross-functional team members & get the documentation ready for certifications and audits. Develop, review and approve the documents as per the regulatory terms. Interact with external audit teams and conduct the audit peacefully. Interact with external accredited labs and regulating agencies, get their inputs and clear the continent specific non-compliant related issues. Prepare the technical file and design related documents for the NPIs in compliant with the regulatory updates. MDR documentation & CE certification readiness. Facing internal & external quality audits and CAPA process.100% DHR compliance for traceability. Final goods performance yield tracking & sustenance. Implement non-conforming material process & resolve rework, scrap or return to vendor. Key Responsibilities: 1. Regulatory Affairs: Build the technical files and drive risk management. Understand parts, processes and performance. Implement engineering change management. Perform regular IQA. Work closely with all cross-functional team members. Review design documents & participate in periodic design reviews. A weekly operating mechanism on project status. Boundary less involvement in new organizational initiatives

2. Quality Assurance: Capture & improve in-process yield metrics Final goods performance yield tracking & sustenance Implement non-conforming material process & resolve rework, scrap or return to vendor Understand parts, processes and performance Implement engineering change management Perform regular IQA Face the quality audits and CAPA process Streamline incoming parts quality & track metrics. Boundary less involvement in new organizational initiatives.

3. Documentation and Reporting: Ensure all regulatory submissions, reports, and records are accurate, complete, and maintained according to company and regulatory standards. Develop and maintain technical files, dossiers, and other regulatory documents for all products. Prepare and present quality and regulatory reports to management.

Qualifications: Bachelor’s degree in a scientific, engineering, or related field. Advanced degree preferred. 8-12 years of experience in Quality Assurance and/or Regulatory Affairs in [relevant industry, e.g., pharmaceuticals, medical devices]. Thorough knowledge of relevant regulatory guidelines (e.g., FDA, EMA, ISO standards). Experience with regulatory submissions and interactions with regulatory bodies. Strong organizational skills, with attention to detail and the ability to manage multiple projects simultaneously. Excellent communication and interpersonal skills, with the ability to work effectively in cross-functional teams.

Preferred Skills: Certification in Regulatory Affairs (RAC) or Quality Assurance. Experience with electronic quality management systems (eQMS). Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).