ISO 13485 Consultant webmaster@wangara August 30, 2023

Job Title: ISO 13485 Consultant

Deadline:  8th September, 2023

Job Summary:

We are seeking a highly skilled and experienced ISO 13485 Consultant to assist our medical diagnostic development and manufacturing social enterprise in achieving ISO 13485 certification. The consultant will play a critical role in guiding us through the certification process, ensuring that our quality management system aligns with international standards and best practices.


  • Provide expert guidance and consultation on the implementation of ISO 13485 standards within our organization.
  • Conduct thorough assessments of our current quality management practices and identify gaps in compliance with ISO 13485 requirements.
  • Develop a comprehensive roadmap and action plan for achieving ISO 13485 certification within the specified timeframe.
  • Collaborate with cross-functional teams to design and implement quality management processes, procedures, and documentation.
  • Conduct training sessions to educate our staff on ISO 13485 requirements, processes, and their roles in maintaining compliance.
  • Assist in the preparation of necessary documentation, including quality manuals, procedures, and work instructions.
  • Conduct internal audits to evaluate the effectiveness of the quality management system and recommend improvements.
  • Liaise with relevant regulatory bodies and certification agencies to ensure a smooth certification process.
  • Monitor and track progress towards ISO 13485 certification milestones and provide regular status reports to management.
  • Continuously update and adapt quality management practices to ensure ongoing compliance with ISO 13485 standards.


  • Bachelor’s degree in a relevant field; advanced degree or certification in quality management is a plus.
  • Proven experience as an ISO 13485 consultant or quality management professional in the medical device or diagnostic industry.


  • Track record of successfully guiding organizations to achieve ISO 13485 certification.
  • Experience working with regulatory agencies and certification bodies is a plus.


Please submit proposals and references to by 8th September