Manager, Quality System and Regulatory Compliance – Medical Devices
Preference will be given to BBEEE candidates due to BEE requirements
Location: Johannesburg
Position overview:
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 [Phone Number Removed];
- Knowledge of the International Regulations QSR for USA, CE Directive and regulations for Europe
Desired Skills:
- life sciences
- medical devices
- QSR
- ISO [Phone Number Removed];
Desired Work Experience:
- 5 to 10 years
Desired Qualification Level:
- Masters
About The Employer:
A global leader in the molecular diagnostics industry has a new opportunity available for a Quality System and Regulatory Compliance Manager.
Employer & Job Benefits:
- Medical Aid
- Provident Fund
- Performance Bonus