Associate Regulatory Affairs Specialist supporting regulatory activities for product registrations and renewals, requiring a Bachelor’s degree in Pharmacy or Life Sciences with 1+ year regulatory affairs experience in medical device or pharmaceutical industry, in a healthcare/medical device environment, hybrid role in Nairobi.
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.
Key Responsibilities
- 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.
