Compliance Manager (Healthcare) in Sigma Software

Compliance Manager (Healthcare) Kyiv, Kharkiv, Lviv, Dnipro, Odessa, Vinnytsia, Ivano-Frankivsk, Lutsk, Poltava, Sumy, Ternopil, Cherkasy, Chernivtsi, Burgas (Bulgaria), Warsaw (Poland), Krakow (Poland), Poznan ( Poland), remotely We are looking for an experienced Compliance Manager, ready to help us develop a quality management system in accordance with standards and regulatory requirements for software in the field of healthcare. You will design, develop and implement compliance policies and procedures, internal audits and risk assessments in accordance with ISO 13485 and IEC 62304. REQUIREMENTS Regulatory knowledge: in-depth understanding of ISO 13485, IEC 62304, GxP guidelines and rules Quality Management System (QMS): experience in establishing and maintaining a QMS in accordance with ISO standards 13485, GxP, IEC 62304 and 21CFR 820 Risk management: the ability to conduct risk assessments and implement risk management processes Computer systems verification (CSV): knowledge of the principles and practices of verification of computer systems related to GxP Compliance with international standards: knowledge of international regulatory requirements, related to ISO 13485, GxP, IEC 62304 and 21CFR 820 standards Auditing: significant experience in conducting internal and external audits in accordance with ISO 13485, GxP, IEC 62304 and 21CFR 820 standards Communication skills: ability to clearly and effectively communicate complex regulatory requirements RESPONSIBILITIES Study and implementation of regulatory acts: be aware of the latest changes in ISO 13485, IEC 62304 and GxP standards to ensure their compliance, transform the complex requirements of ISO 13485 and IEC 62304 into effective policies and procedures. internal audits to identify compliance gaps and areas for improvement Training and education: train employees to understand and comply with ISO 13485 and IEC 62304 compliance requirements inform staff about the significance and consequences of non-compliance Risk assessment and management: identify potential compliance risks associated with ISO 13485, IEC 62304 and GxP standards develop implement strategies to reduce identified risks Stay abreast of regulatory changes: stay abreast of changes in ISO 13485, IEC 62304, GxP and related regulatory documents or best practices __________________________________________________________________________________________ Weare looking for anexperienced Compliance Manager to helpus build QMS in accordance with healthcare software standards and regulations. You will manage, design, and implement compliance policies and procedures, internal audits, and risk assessments in alignment with ISO 13485 and IEC 62304 standards. REQUIREMENTS Regulatory Knowledge: in-depth understanding ofISO 13485, IEC 62304, GxP guidelines and regulations Quality Management Systems (QMS): experience establishing and maintaining QMS compliant with ISO 13485, GxP, IEC 62304, and 21CFR 820 Risk Management: proficiency in conducting risk assessments and implementing risk managementement processes Computer System Validation (CSV): familiarity with the principles and practices ofcomputer system validation related toGxP Compliance with International Standards: knowledge ofinternational regulatory requirements relevant toISO 13485, GxP, IEC 62304, and 21CFR 820 Auditing: strong background inconducting internal and external audits under ISO 13485, GxP, IEC 62304, and 21CFR 820 standards Communication Skills: ability tocommunicate complex regulatory requirements clearly and effectively RESPONSIBILITIES Interpreting and Implementing Regulations: stay updated with ISO 13485, IEC 62304, and GxP regulations toensure compliance translate complex ISO 13485 and IEC 62304 requirements into actionable policies and procedures Policy Development: develop and maintain compliance policies, procedures, and guidelines for ISO 13485 and IEC 62304 Monitoring and Auditing: monitor ongoing compliance with ISO 13485, IEC 62304, and GxP conduct internal audits toidentify compliance gaps and areas for improvement Training and Education: train employees tounderstand and adhere toISO 13485 and IEC 62304 compliance requirements educate staff onthe implications and consequences ofnon-compliance Risk Assessment and Management: identify potential compliance risks related toISO 13485, IEC 62304, and GxP develop and implement strategies tomitigate identified risks Staying Current with Regulatory Changes: keep abreast ofchanges inISO 13485, IEC 62304, GxP, and related regulations orbest practices