Compliance Manager (Healthcare) in Sigma Software Group

Company DescriptionWe are looking for an experienced Compliance Manager to help us 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.Job DescriptionInterpreting and Implementing Regulations: stay updated with ISO 13485, IEC 62304, and GxP regulations to ensure 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 to identify compliance gaps and areas for improvement Training and Education: train employees to understand and adhere to ISO 13485 and IEC 62304 compliance requirements; educate staff on the implications and consequences of non-compliance Risk Assessment and Management: identify potential compliance risks related to ISO 13485, IEC 62304, and GxP; develop and implement strategies to mitigate identified risks Staying Current with Regulatory Changes: keep abreast of changes in ISO 13485, IEC 62304, GxP, and related regulations or best practices QualificationsRegulatory Knowledge: in-depth understanding of ISO 13485, IEC 62304, GxP guidelines and regulations Quality Management Systems (QMS): experience in establishing and maintaining QMS compliant with ISO 13485, GxP, IEC 62304, and 21 CFR 820 Risk Management: proficiency in conducting risk assessments and implementing risk management processes Computer System Validation (CSV): familiarity with the principles and practices of computer system validation related to GxP Compliance with International Standards: knowledge of international regulatory requirements relevant to ISO 13485, GxP, IEC 62304, and 21 CFR 820 Auditing: strong background in conducting internal and external audits under ISO 13485, GxP, IEC 62304, and 21 CFR 820 standards Communication Skills: ability to communicate complex regulatory requirements clearly and effectively Show more Show less Посадовий рівень Старший середній рівень Тип зайнятості Повний робочий день Посадові обов’язки Юридична сфера Галузі Розробка програмного забезпечення