About MEDTL: MEDTL is an innovative healthcare technology company specializing in AI-powered solutions for cardiovascular disease detection. Our mission is to develop state-of-the-art, non-invasive critical care monitoring tools that provide real-time insights, enhance patient outcomes, and set new standards in medical technology. 聽Role Overview: We are looking for a Quality Manager to lead regulatory compliance and quality assurance initiatives. This role is pivotal in ensuring our products meet international regulatory standards such as FDA 510(k), CE (MDR 2017/745), and ISO 13485. The ideal candidate will implement and maintain a robust Quality Management System (QMS) while driving continuous improvement efforts. Key Responsibilities:
路聽聽聽聽Lead and manage certification processes, including FDA 510(k), CE (MDR 2017/745), and ISO 13485 approvals. 路聽聽聽聽Develop and maintain regulatory documentation and compliance protocols. 路聽聽聽聽Establish and implement quality assurance frameworks aligned with medical technology standards. 路聽聽聽聽Maintain and improve the Quality Management System (QMS) for medical devices to support compliance and operational excellence. 路聽聽聽聽Identify and mitigate regulatory and operational risks related to product compliance. 路聽聽聽聽Conduct risk assessments and ensure adherence to global health, safety, and regulatory policies. 路聽聽聽聽Conduct internal audits on QMS efficiency and compliance. 路聽聽聽聽Organize and lead compliance training for internal teams.
路聽聽聽聽Provide regular updates to the Managing Director on certification progress, operational metrics, and key strategic initiatives. 路聽聽聽聽Prepare and present monthly and quarterly reports with actionable insights for decision-making. Qualifications/Required Skills/Experience: 路聽聽聽聽Proven experience in quality assurance, certification, and regulatory compliance in the medical technology or healthcare industry. 路聽聽聽聽聽Deep knowledge of FDA 510(k), CE (MDR 2017/745), ISO 13485, and related regulatory frameworks. 路聽聽聽聽Strong expertise in risk management, compliance frameworks, and QMS for medical devices implementation. 路聽聽聽聽Excellent communication, leadership, and problem-solving skills. 路聽聽聽聽Ability to work independently and drive regulatory strategies. Preferred Skills (Optional):
路聽聽聽聽Experience with IEC 62304 (medical software lifecycle processes) and ISO 14971 (risk management for medical devices). 路聽聽聽聽Familiarity with cybersecurity standards for medical software (e. g. , ISO 27001, FDA cybersecurity guidance). 路聽聽聽聽Background in AI-based medical software compliance and validation. 聽 Apply: Send your CV to info@mymedtl. com with the subject line "Quality Manager Application". Join MEDTL and be part of a team shaping the future of AI-driven cardiovascular diagnostics
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