Quality Assurance & Regulatory Affairs Manager

at  Unique Personnel

COMPUTER SKILLS

ERP,ISO 9001,ISO13485,OHSAS 18001,ISO 14000,SAHPRA,MARS,MS Office,QMS,SANS

JOB DESCRIPTION

Reporting to the Chief Financial Officer

INHERENT REQUIREMENTS

Required Education, experience & exposure:

• Qualifications, degree or equivalent in quality assurance and regulatory affairs management.
• Have a minimum of 5 years’ experience in quality control and servicing within the medical equipment industry, or similar and applicable environment.
• Exposure to infection control processes and practices
• Exposure to multi-company, multi-divisional and regional structures and consolidation thereof.
• Exposure to African Activity/transactions, including multi-currency transactions.
• Good knowledge of over corporate structures, divisional, departmental and process interrelations.
• Exposure to developing and execution on tactical strategy from corporate strategy.
• Sound knowledge of ERP systems, process integration.
• Knowledge of cause and effect analysis (root cause analysis)
• Working knowledge of corporate IT System and ERP Solutions
• Exposure to ISO 9001 standards, (preferably ISO13485),
• Good knowledge of Occupational Health & Safety Regulations. OHSAS 18001,
• Good knowledge of ISO 14000, including Waste management standards
• Exposure to National Building Standards beneficial,
• Exposure to applicable regulatory standards and legislation, and applicable compliance activities. (SAHPRA & MARS)

Key Personal Attributes and Characteristics:

• Business Acumen a must, ethical and compliant character.
• Confident leader, backed by technical facts and know how.
• Ability to communicate (verbal and written) and guide staff/peers and other managers at all levels.
• Ability to challenge constructively senior management.
• Companionate yet assertive. (Ability to follow through).
• Good presentation skills. Including ability to impart knowledge (i.e. training)
• Well organized and ability to handle multiple activities, at different levels. Deadline driven.
• Ability to execute at delegated authorisation levels, and ability to execute under pressure without compromising standards,
• Ability to plan, monitor and control under pressurized circumstances. (Maintain composure).
• Ability to motivate and guide a team of diverse backgrounds and cultures.
• Mature, high energy performer

WHAT QUALIFICATION

Quality assurance and regulatory affairs management.

MINIMUM QUALIFICATION

Bachelors

Please refer the Job description for details