Associate Regulatory Affairs Specialist – Nairobi
TestHiring · Nairobi
Job description
About the role
We are looking for an Associate Regulatory Affairs Specialist to join our team in Nairobi. The role supports product importation and registration activities, ensuring smooth market entry and compliance across assigned territories.
Key responsibilities
- Coordinate with regional Regulatory Affairs and product release teams to resolve blocked orders and minimise supply interruptions.
- Collect, review and organise regulatory documentation for tender submissions in designated markets.
- Manage product registration and renewal processes, including sourcing documents, compiling submission packages and tracking approval status with authorities.
- Collaborate with global and regional stakeholders on new product launches and regulatory implementation.
- Provide regulatory information and documentation for country‑specific business and compliance projects.
- Maintain regulatory databases, trackers and document‑control systems to ensure data accuracy and audit readiness.
- Monitor registration timelines and follow up with stakeholders to achieve timely approvals.
- Support adherence to Medtronic policies, quality standards and national regulatory requirements.
Required profile
- Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Medical Sciences or a related scientific discipline.
- At least 1 year of regulatory affairs experience in medical devices, pharmaceuticals, healthcare or life‑sciences.
- Experience with regulatory submissions, registrations, renewals or product compliance activities.
- Fluent written and spoken English.
- Ability to manage multiple projects, deadlines and documentation simultaneously.
Required skills
- Microsoft Excel
- Microsoft Word
- Microsoft PowerPoint
- Regulatory databases
- Document management systems
- Compliance tracking tools
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Published 3 weeks ago
Expires 1 month from now
44 views · 0 interested
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TestHiring
Nairobi