Regulatory Affairs & Quality Assurance Specialist

Summary:
As a Regulatory Affairs and Quality Assurance Specialist you will be primarily responsible for the integration and upkeep of the site Total Quality Management System including all National and Corporate policies and procedures in accordance with ISO13485. The role will include ensuring company compliance with sound QA and RA principles and related to all medical devices in SADC including GMP, SOP’s, audits, training and customer complaints.

Requirements:
• As a Regulatory Affairs and Quality Assurance Specialist you should have a knowledge of ISO13485 implementation and upkeep
• Previous experience in Quality Assurance and/or Regulatory Affairs
• Fluency in English language

Other skills:
• Excellent communication skills
• Self-motivated
• Good time management skills
• Able to work under pressure
• Flexible
• Route cause analysis

Responsibilities:
• As a Regulatory Affairs and Quality Assurance Specialist you will be responsible for the upkeep of Compliance to RA and QA systems
• ISO and other RA or QA systems implementation and upkeep
• Audits internal and external (conduct and assist)
• On-going QA and RA review and monitoring of compliance against established key performance indicators
• Follow-up and report back on post market surveillance activities entered into the relevant systems for processing;