TestHiring
Require an Associate Regulatory Affairs Specialist in Nairobi, Kenya
Nairobi, KEOn-sitePermanentFull-time
Posted Sep 11, 2026
- Support regulatory requirements related to product importation by coordinating with regional Regulatory Affairs teams and product release teams to resolve blocked orders and minimise supply interruptions.
- Collect, review, and organise regulatory documentation required to support tender submissions across assigned markets.
- Coordinate product registration and renewal activities, including sourcing regulatory documents, compiling submission packages, and tracking approval progress with regulatory authorities.
- Collaborate with global and regional stakeholders to support new product launch plans and regulatory implementation activities.
- Provide regulatory information and documentation required to support 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 relevant stakeholders to support timely regulatory approvals.
- Support compliance with Medtronic policies, quality standards, and national regulatory requirements across assigned territories.
Requirements
- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Medical Sciences, or a related scientific discipline and 1+ years of regulatory affairs experience within the medical device, pharmaceutical, healthcare, or life sciences industry.
- Experience supporting regulatory submissions, registrations, renewals, or product compliance activities.
- Fluent written and verbal English communication skills.
- Experience working with Microsoft Office applications, including Excel, Word, and PowerPoint.
- Ability to manage multiple projects, deadlines, and regulatory documentation requirements simultaneously.
Preferred Qualifications:
- Experience supporting regulatory activities across multiple countries or regions.
- Knowledge of medical device regulatory requirements and product registration processes.
- Experience working with regulatory databases, document management systems, or compliance tracking tools.
- Experience collaborating with global, regional, and cross-functional stakeholders.
- Knowledge of tender support processes and importation requirements within healthcare markets.
Role snapshot
Job type
Full-time
Required skills
Regulatory submissions preparationProduct registration and renewal coordinationRegulatory documentation collection and reviewRegulatory databases and document control maintenanceMonitoring registration timelines and approval trackingTender support and importation coordinationCross-functional and global/regional stakeholder collaborationRegulatory compliance with policies and quality standardsAudit readiness and data accuracy managementProject and deadline management (multitasking)Microsoft Office (Excel, Word, PowerPoint)Fluent written and verbal English communication
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