Compliance Manager (Healthcare)

We 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.

Requirements:
Regulatory 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

Responsibilities:
Interpreting 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

About Sigma Software

Sigma Software is a place where Nordic Traditions meet Ukrainian Spirit to create Superior Software. We combine the best practices and approaches from Swedish and Ukrainian cultures. Taking high demand for quality, minimal hierarchy, freedom of decision-making, and attention to every opinion from Swedes, as a Ukrainian company we demonstrate flexibility and dedication to every project and every customer.

We are IT consulting and software product company with development offices in Ukraine, Sweden, the USA, Canada, Poland, and Australia. We deliver smartest solutions to our customers in the areas of government, telecommunications, advertising, automotive, gaming, and others. Being a part of Sigma Group, one of the largest Nordic IT corporations, we are a global player with more than 5000 employees in 12 countries and over 1500 in Ukraine.

We work with startups, software houses, and enterprises providing the products and services that suit our clients the most. Company`s R&D centers are mastering the trending technologies and directions: Infotainment, AR/VR, Blockchain, Machine Learning, Data Science, Artificial Intelligence, and others.

Company website:
https://career.sigma.software/

DOU company page:
https://jobs.dou.ua/companies/sigma-software/