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Require an Associate Regulatory Affairs Specialist in Nairobi, Kenya

TestHiring
Posted 12 days ago, valid for 8 days
Location

Nairobi, Nairobi County

Salary

Competitive

Contract type

Full Time

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Sonic Summary

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  • The job involves supporting regulatory requirements for product importation and coordinating with various teams to resolve order issues and minimize supply interruptions.
  • Candidates must have a Bachelor's degree in a relevant scientific discipline and at least 1 year of regulatory affairs experience in the medical device or healthcare industry.
  • Key responsibilities include managing regulatory documentation for tender submissions, coordinating product registrations, and maintaining regulatory databases for compliance and audit readiness.
  • The role also requires effective collaboration with global and regional stakeholders to support new product launches and ensure adherence to Medtronic policies and national regulations.
  • The position offers a competitive salary, commensurate with experience, and emphasizes the importance of strong communication skills and the ability to manage multiple projects.

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  • 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.

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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.





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