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Associate Regulatory Affairs Specialist at Medtronic
Medtronic
September 12, 2026
Full-time
On-site
A Day in the Life
The Regulatory Affairs function supports the registration, maintenance, and compliance of Medtronic products across multiple markets, enabling timely access to therapies and uninterrupted product availability. This role provides regulatory support for the Adriatic East, Adriatic West, Central Africa, and other assigned markets by coordinating product registrations, renewals, importation requirements, tender support activities, and regulatory documentation with local, regional, and global stakeholders.
This position is based in Nairobi, Kenya and operates under a Flex work model, combining office-based and remote working arrangements. Travel is expected up to 20% to support business and regulatory activities across the assigned region.
The Associate Regulatory Affairs Specialist supports regulatory activities required to maintain product registrations, enable market access, and ensure compliance with applicable regulatory requirements across assigned countries. The role partners with regional and global teams to support product registrations, renewals, importation requirements, tender submissions, and regulatory data management activities.
Responsibilities may include the following and other duties may be assigned:
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.
Required Knowledge and Experience:
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.
The Regulatory Affairs function supports the registration, maintenance, and compliance of Medtronic products across multiple markets, enabling timely access to therapies and uninterrupted product availability. This role provides regulatory support for the Adriatic East, Adriatic West, Central Africa, and other assigned markets by coordinating product registrations, renewals, importation requirements, tender support activities, and regulatory documentation with local, regional, and global stakeholders.
This position is based in Nairobi, Kenya and operates under a Flex work model, combining office-based and remote working arrangements. Travel is expected up to 20% to support business and regulatory activities across the assigned region.
The Associate Regulatory Affairs Specialist supports regulatory activities required to maintain product registrations, enable market access, and ensure compliance with applicable regulatory requirements across assigned countries. The role partners with regional and global teams to support product registrations, renewals, importation requirements, tender submissions, and regulatory data management activities.
Responsibilities may include the following and other duties may be assigned:
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.
Required Knowledge and Experience:
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.