Ivd Regulation

**Main purpose of the job**:

- To work with a multi-disciplinary team of clinicians, pathologists, scientists, and engineers to develop and evaluate new laboratory diagnostics and ensure compliance according to SAHPRA regulations for RUO and IVD

**Location**:

- **Wits Medical School (7 York Road, Parktown) and Spencer Lister Building (Braamfontein) - Johannesburg**

**Key performance areas**:

- Manage SAHPRA registration for medical devices, clinical trials, and digital health technologies
- Have a full understanding of the Medicines and Related Substance Act 101 of 1965
- Have a full understanding of ISO13485 standard and the IVD Industry
- Knowledge of ISO15189 would be an advantage for quality diagnostics
- Manage ethical, legal, and contraction framework for a portfolio of innovations
- Engage with SAHPRA officials and developers
- Translate technical information to non-specialists
- Keep the team updated on international regulatory and quality information

**Required minimum education and training**:

- **BSc (relevant field) with Diploma in Management (or equivalent) and minimum 2 years of relevant working experience
***Required minimum work experience**:

- **Minimum of 2 years working experience in the healthcare regulation industry**

**Desirable additional education, work experience, and personal abilities**:

- Self-motivated and well organized
- Good work ethic and good communication skills
- Good understanding of molecular & genomic diagnostics (point of care and centralized laboratory) and digital health technologies
- Good understanding of laboratory medicine and quality needs for diagnostics
- Ability to engage at all levels with legal, contractual and financial team members
- Experience in global health
- Experience in project management
- Clinical trial registration for infectious disease diagnostics and/or digital health technologies is an advantage

**TO APPLY**:

- Only if you do meet the minimum job requirements and experience as mentioned above, you may submit a detailed updated CV.
- _AJ Personnel is fully POPIA Compliant._
- Please take note that the applicants who do not adhere to the above criteria will not be considered for the respective position.
- Note WHC, in accordance with their Employment Equity goals and plan, will give preference to suitable applicants from designated groups as defined in the Employment Equity Act 55 of 1998 and subsequent amendments thereto.
- PLEASE NOTE: Our Client, WHC, maintains mandatory Covid-19 requirements, and as such only Covid-19 vaccinated incumbents will be considered for positions.

**Please note**:

- AJ Personnel is only responsible for advertising the advertisement on behalf of their client Wits Health Consortium.
- AJ Personnel does not have any salary or other information regarding the position.