Compliance Manager
2 weeks ago
**1. Compliance Management**:
- Oversee all aspects of compliance with regulatory requirements, industry standards, and internal policies.
- Lead efforts to obtain and maintain certifications (e.g., ISO, AIZO, and other relevant quality/compliance standards).
- Ensure ongoing adherence to all applicable regulations, proactively identifying and addressing areas for improvement.
- Review, update, and maintain all regulatory files and documentation, ensuring timely submissions and filings.
- Monitor and interpret changes in laws, regulations, and industry standards; advise management on compliance implications.
**2. Quality Assurance**:
- Implement and manage the company’s Quality Management Systems (QMS).
- Collaborate with operations, product, and other teams to ensure products, services, and processes meet compliance and quality benchmarks.
- Conduct regular internal audits and assessments to evaluate compliance and certification readiness.
- Drive continuous improvement in quality processes through monitoring, feedback, and corrective action.
**3. Risk Management & Reporting**:
- Develop and implement a risk management strategy to address potential non-compliance or quality issues.
- Maintain a compliance and certification risk register, ensuring risks are documented and mitigated.
- Monitor and report on the company’s compliance status, providing regular updates to senior leadership.
- Investigate and resolve compliance-related issues or incidents, ensuring thorough root-cause analysis and preventive measures.
**4. Collaboration & Leadership**:
- Partner with operations, product, and cross-functional teams to embed compliance into daily workflows.
- Act as the primary liaison for regulatory bodies, certification auditors, and external inspections.
- Provide training, awareness programs, and guidance to employees on compliance standards, policies, and regulatory requirements.
- Foster a culture of integrity, accountability, and continuous learning across the organization.
**5. Process Improvement**:
- Lead continuous improvement initiatives to streamline compliance and certification processes.
- Enhance efficiency by automating and simplifying compliance workflows where possible.
- Stay updated on new regulations, compliance frameworks, and industry trends to anticipate and prepare for potential business impacts.
- Benchmark internal processes against best practices and recommend process optimizations.
**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.
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