Regulatory Compliance and Quality Management

3 weeks ago


Pretoria, South Africa Measured Ability Group Holdings Full time

**South Africa - Gauteng**, Tshwane (Pretoria / Shoshanguve / Bronkhorstspruit)**

**Our client a manufacturer of medical devices is seeking a Regulatory compliance and Quality management systems specialist.**

**Regulatory Compliance**
**Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings.**
**Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards.**
**Assist in creation and maintenance of regulatory files.**

**Ensure that international and national legislation are applied and adhered to.**

**Write, analyze, and edit technical documents to support country-specific regulatory submissions.**
**Compile submissions in a format consistent with applicable guidance documents, including**

**investigational device submissions in RSA, USA, Canada and Europe.**

**QMS**
**Implements, manages, maintains, oversees, administrates, and improves ISO 13485 requirements and the quality management system.**
**Ensure that all facets of the organisation comply with ISO 13485. Ensure that current processes are consistent with established QMS and legal standards.**
**Initiate new SOPs as and when required, as per company needs.**

**Ensure that new procedures or any procedure changes are updated to reflect current practice.**

**QUALIFICATIONS**
**Relevant Tertiary Qualification in the field of Biotechnology/Biomedical science/Pharmaceutical science and Quality**

**Proven knowledge of ISO 13485 and lead auditor certification**

**Minimum of 3 years of working experience in a Quality related field, in the medical device industry. Advanced computer and Excel skills**
**The ability to communicate effectively in English (written and spoken word)**
- For more information please contact:
**Ashleigh Van Wyk


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