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Regulatory Affairs Specialist Africa at Terumo BCT
JobSearch
Nairobi 🇰🇪 Kenya
Posted 1 day ago (24 Sep 2026) Updated about 4 hours ago
Job Description
The Regulatory Affairs Specialist will develop and execute strategies to obtain and maintain medical device registrations across African markets. Responsibilities include preparing dossiers, coordinating submissions, managing timelines and ensuring compliance with regional regulations. The role requires strong knowledge of African medical device standards and quality systems.
Qualifications & Requirements
- • Bachelor’s degree in a relevant field (BA/BSc/HND).
- • 3–7 years of experience in regulatory affairs for medical devices, with strong knowledge of African regulations and quality management systems.
Required Skills
Responsibilities
- • Prepare, compile, review and submit medical device registration dossiers to health authorities across Africa.
- • Develop regulatory submission strategies to support product launches and business objectives.
- • Coordinate new registrations, renewals, amendments, change notifications and licence maintenance activities.
- • Manage regulatory timelines to ensure timely approvals and renewals.