About the role As the Compliance Manager, you will be responsible for ensuring that PaxeraHealth remains fully compliant with all relevant industry regulations and standards, particularly in the areas of quality assurance, regulatory compliance, and ISO standards (AIZO). This role is pivotal in maintaining our company’s commitment to excellence and regulatory adherence, ensuring that all departments are aligned with compliance policies. The Compliance Manager will focus on overseeing the regulatory files, maintaining compliance with industry standards, and leading the implementation of quality management systems. You will collaborate closely with internal teams, regulatory bodies, and management to ensure seamless regulatory processes. Responsibilities
Compliance Management:
Oversee all aspects of compliance related to regulatory requirements, industry standards, and internal policies.
Lead the effort in obtaining and maintaining certifications such as ISO and other relevant quality and compliance standards (AIZO).
Ensure ongoing adherence to all applicable regulatory requirements, identifying any areas for improvement.
Review and maintain all regulatory files and documentation, ensuring timely updates and filings.
Quality Assurance:
Implement and manage the company’s quality management systems.
Collaborate with relevant departments to ensure that products, services, and processes meet required quality and compliance benchmarks.
Conduct regular internal audits and assessments to monitor compliance performance and drive continuous improvement in quality processes.
Risk Management & Reporting:
Develop and implement a risk management strategy that addresses potential non-compliance or quality issues.
Monitor and report on the company’s compliance status, providing regular updates to senior leadership.
Investigate and resolve any compliance-related issues or incidents, ensuring root-cause analysis and preventive actions.
Collaboration and Leadership:
Work closely with the operations and product teams to ensure compliance is integrated into the day-to-day workflow.
Act as the point of contact for regulatory agencies, audits, and inspections.
Provide training and guidance to employees on compliance standards, policies, and regulatory requirements.
Process Improvement:
Lead continuous improvement initiatives to streamline compliance-related processes and ensure efficiency.
Proactively stay updated on new regulations and compliance trends within the industry to anticipate potential impacts on the business.
Key Performance Indicators (KPIs):
Achieve and maintain all required certifications (ISO, AIZO, etc.).
Ensure 100% compliance with regulatory filing deadlines and requirements.
Conduct and report on quarterly internal audits with clear actions for improvement.
Successfully manage and resolve any compliance incidents within the stipulated timeframes.
Drive improvements in the quality management system with measurable outcomes (e.g., reduction in non-conformities).
Qualifications and Skills:
Bachelor’s degree in compliance, regulatory affairs, business administration, or related field.
At least 3-5 years of experience in compliance, regulatory management, or quality assurance, ideally within the healthcare or software industry.
Strong knowledge of industry regulations, quality standards (ISO), and compliance processes.
Excellent English Language.
Excellent organizational, leadership, and communication skills.
Ability to manage multiple projects and deadlines in a fast-paced environment.
