Manager Quality System and Regulatory Compliance - Medical Devices

SUMMARY:
Manager Quality System and Regulatory Compliance

POSITION INFO:

Preference will be given to BBEEE candidates due to BEE requirements

Location: Johannesburg

Position overview:

A global leader in the molecular diagnostics industry has a new opportunity available for a Quality System and Regulatory Compliance Manager. One will manage QSM processes and related deliverables in conjunction with company objectives and regulatory requirements, as well as mentor and provide ongoing teaching, guidance and assistance of process owners, CAPA stakeholders, internal auditors, managers and their teams.

One will also interact with global QS counterparts in the headquarter and ensure the good alignment of QS processes, whilst ensuring timely communication to domestic competent authorities for submission and post-market regulatory compliance.

Qualifications and Experience:

• Masters degree in the Life Sciences
• 5 Years related work experience in the medical devices industry (IVD beneficial)
• Excellent English communication skills
• Knowledge of International Organizations for Standardization ISO 9001-13485
• Knowledge of the International Regulations QSR for USA, CE Directive and regulations for Europe

If you meet all the requirements specified above, and interested to further the process, kindly contact Patricia on----- or send your detailed CV to <--------Please upload your CV here--------

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