Quality Manager

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.  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:

·    Lead and manage certification processes, including FDA 510(k), CE (MDR 2017/745), and ISO 13485 approvals. ·    Develop and maintain regulatory documentation and compliance protocols. ·    Establish and implement quality assurance frameworks aligned with medical technology standards. ·    Maintain and improve the Quality Management System (QMS) for medical devices to support compliance and operational excellence. ·    Identify and mitigate regulatory and operational risks related to product compliance. ·    Conduct risk assessments and ensure adherence to global health, safety, and regulatory policies. ·    Conduct internal audits on QMS efficiency and compliance. ·    Organize and lead compliance training for internal teams.

·    Provide regular updates to the Managing Director on certification progress, operational metrics, and key strategic initiatives. ·    Prepare and present monthly and quarterly reports with actionable insights for decision-making. Qualifications/Required Skills/Experience: ·    Proven experience in quality assurance, certification, and regulatory compliance in the medical technology or healthcare industry. ·     Deep knowledge of FDA 510(k), CE (MDR 2017/745), ISO 13485, and related regulatory frameworks. ·    Strong expertise in risk management, compliance frameworks, and QMS for medical devices implementation. ·    Excellent communication, leadership, and problem-solving skills. ·    Ability to work independently and drive regulatory strategies. Preferred Skills (Optional):

·    Experience with IEC 62304 (medical software lifecycle processes) and ISO 14971 (risk management for medical devices). ·    Familiarity with cybersecurity standards for medical software (e. g. , ISO 27001, FDA cybersecurity guidance). ·    Background in AI-based medical software compliance and validation.   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