ISO Compliance Officer

About the Role

MedSolutions is seeking a dedicated ISO Compliance Officer to ensure that our company's processes and systems fully comply with ISO standards and all applicable regulatory compliance requirements. In this role, you will be responsible for developing, implementing, and maintaining the organization's ISO compliance programs. You will work closely with various departments including working closely with clinical validation to ensure adherence to quality management standards, uphold regulatory compliance, and drive continuous improvement across the organization.

As the ISO Compliance Officer, your primary duties will include:

• Development, Maintenance, and Clinical Validation Support

• Develop and maintain the organization's ISO and regulatory compliance programs.

• Develop, update, and maintain all ISO and regulatory-related documentation, including work instructions, policies, and procedures.

• Monitor any changes in ISO standards and relevant regulatory guidelines, updating our compliance programs accordingly.

• Provide clinical validation support by ensuring that all validation protocols, procedures, and reports strictly align with ISO standards and regulatory requirements.

Auditing and Reporting

• Conduct regular internal audits to guarantee adherence to ISO standards and regulatory compliance.

• Identify areas of non-compliance, document them, and collaborate with relevant departments—including clinical validation teams—to implement corrective actions.

• Coordinate and facilitate certification processes, external audits, and regulatory inspections.

• Report on the overall status of ISO and regulatory compliance directly to senior management.

Training and Continuous Improvement

• Provide guidance and training to employees regarding ISO standards, regulatory compliance requirements, and quality expectations for clinical validation.

• Promote a culture of quality management, regulatory adherence, and continuous improvement throughout the entire organization.

Qualifications

Education & Experience

• A Bachelor's degree in Quality Management, Engineering, Business Administration, Bachelor of Science, or a related field.

• A minimum of 3 to 5 years of professional experience in ISO compliance and quality management.

• Proven experience in managing ISO certification processes and conducting internal audits.

Operational & Technical Skills

• In-depth knowledge of ISO 9001 & ISO 13485 as well as other relevant ISO standards.

• Strong problem-solving and analytical skills.

• Excellent documentation and organizational skills.

• Proficiency in utilizing quality management tools and software.

• A strong understanding of methodologies for process improvement.