Contract ( Ftc) - Ra Specialist

Abbott

Johannesburg, South Africa
Not specified; base pyy n/a; range may vary by loc...
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Medical devices regulatory affairs experience
Ivd regulatory environment knowledge
Project management in cross-functional teams
** Abbott is seeking a Regulatory Affairs Specialist for a one-year fixed-term contract in Johannesburg, South Africa. The ideal candidate will coordinate regulatory activities for the company's Rapid Diagnostics Infectious Disease Business Unit, focusing on regulatory submissions and compliance for medical devices, specifically in vitro diagnostics. **

Job Summary

  • This role supports the Abbott Rapid Diagnostics Infectious Disease Business Unit by managing regulatory activities across a designated list of countries.
  • The incumbent will coordinate the IVDR transition project and manage change control dossiers in collaboration with global teams and manufacturing sites.
  • Candidates must have a minimum of one year of experience in Regulatory Affairs within the Medical Devices sector, ideally focusing on IVDs.

Matching Summary

Match Score: 75

** Abbott is seeking a Regulatory Affairs Specialist for a one-year fixed-term contract in Johannesburg, South Africa. The ideal candidate will coordinate regulatory activities for the company's Rapid Diagnostics Infectious Disease Business Unit, focusing on regulatory submissions and compliance for medical devices, specifically in vitro diagnostics. **

Salary

Not specified; Base pay N/A; Range may vary by location

Skills & Requirements

Must-have

  • Medical Devices Regulatory Affairs experience
  • IVD regulatory environment knowledge
  • Project management in cross-functional teams
  • Knowledge of local MOH regulations
  • English written and oral communication skills

Nice-to-have

  • Experience with IVDR transition projects
  • Strong interpersonal and diplomatic skills
  • Ability to maintain high confidentiality
  • Attention to detail in database management

Key Requirements

  • BSc or equivalent degree
  • Minimum 1 year experience in Regulatory Affairs
  • Experience in Medical Devices or IVDs
  • Available to start mid-February or early March

Work Rights

Not specified

Tailored Resume

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