Regulatory & Compliance Manager

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Job Description:

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 9001,ISO 27000, ISO 13485, FDA , MDR, 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
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
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
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
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
Experience with obtaining ISO 9001,ISO 27000, ISO 13485, FDA , MDR
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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