Job summary

Job Ref:
BEE Position:
Johannesburg, South Africa, Africa
Job type:
Full time

QA & Regulatory Affairs Manager

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About this job

Reporting to the CFO, our client is seeking a suitably qualified, high energy performer with drive, for this varied and challenging position.

Key Result Areas

ISO 9001

  • Fulfil the requirements of Quality Systems Manager as per ISO 9001;
  • Design, documentation and rollout of quality management practices in compliance with documented company policies and procedures;
  • Implementation and monitoring of quality management system (QMS) through a central reporting database
  • Ensure compliance to QMS through conducting regular internal reviews/audits;
  • Facilitate the external audit on the ISO 9001 system and address timeously any major and/or minor nonconformances raised;
  • Ensure management meetings are held on a regular basis in compliance with set frequencies;
  • Provide a monthly risk assessment report on the effectiveness of the QMS.

ISO 13485

  • Establish the requirements for compliance with ISO 13485 in accordance with applicable frameworks;
  • Perform regular internal audits to ensure compliance with specific ISO 13485 requirements;
  • Provide a monthly risk assessment report on the effectiveness of the QMS.
  • Conduct Supplier Risk Assessments when required;
  • Perform customer surveys as required to establish trends.
  • Ensure equipment used in technical is calibrated and safe for use;
  • Manage applicable legislative requirements in terms of Labour Inspections;
  • Recall procedure exposure;

Health and Safety Officer Duties:

  • Perform the tasks and assume responsibility as Company Health and Safety Officer;
  • Assume full responsibility for Health and Safety Issues in the company, including First Aid, Fire and
  • Prepare all necessary documentation and provide necessary guidance in terms of all health and safety requirements for projects and other site installations, including but not limited to site risk assessments, representative appointments, assignment of responsibility etc.

Other Legislation Compliance:

  • Keep abreast of industry developments on applicable and relevant legislations, including but not limited to MARS Act, Department of Radiation Regulations, etc;
  • Liaise with Product Managers and compile the required documentation files for registration of products in accordance with specific requirements of Department of Radiation, and maintenance of registration register;
  • Communication of industry developments in a monthly report, and highlight immediately any risks the company may be facing;


Skills Required


  • Bachelor Degree or other relevant qualification

Experience and Skills

  • Minimum of 5 years’ experience in quality control and servicing within the medical equipment industry, or similar and applicable environment
  • Knowledge of SAHPRA legislation/regulations
  • Knowledge of infection control procedures
  • Exposure to internal and external audit
  • Good root cause analysis exposure
  • Good communication skills (written and verbal)
  • Be a team player with the ability to maintain independent approach and assume accountability


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