Regulatory & Compliance Manager

Job Description:

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 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.

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.

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