J
Medical Device Regulatory Affairs Strategist at Oracle
JobSearch
Nairobi 🇰🇪 Kenya
Posted 4 days ago (3 Sep 2026) Updated about 3 hours ago
Job Description
The Medical Device Regulatory Affairs Strategist develops and implements regulatory strategies for health‑related products across Middle East and Africa, ensuring compliance with regional authorities and internal quality standards.
Required Skills
Responsibilities
- • Assess product functionality and devise regulatory strategies for target markets
- • Prepare and manage submissions to health authorities such as SFDA, MOHAP, MOPH, NHRA, SAHPRA, NAFDAC, EDA and PPB
- • Maintain regulatory documentation, technical files and post‑market surveillance records
- • Support internal and external audits, identify gaps and implement corrective actions
- • Advise internal teams on standards, regulations and quality‑management system requirements
- • Lead regulatory projects, review labeling and marketing materials for compliance
- • Monitor changes in global regulatory requirements and update strategies accordingly