About the Opportunity

Our client, a global leader in healthcare and diagnostics, is seeking a highly motivated Regulatory Affairs Specialist, Business Solutions – Diagnostics to support regulatory activities across East Africa. This role is ideal for a regulatory professional with strong experience in diagnostics, medical devices, or in vitro diagnostics (IVD) who is passionate about ensuring regulatory compliance, accelerating market access, and supporting healthcare innovation across the region.

Key Responsibilities

Regulatory Strategy & Market Access

• Develop and execute regulatory strategies for diagnostic products across East African markets.
• Monitor regulatory changes, legislation, and evolving market requirements.
• Support regulatory advocacy initiatives and engage with health authorities and industry stakeholders.
• Contribute to healthcare policy discussions and regulatory convergence initiatives.

Registration & Product Lifecycle Management

• Prepare, compile, and submit regulatory dossiers and registration applications.
• Manage registration approvals, renewals, variations, and product maintenance activities.
• Maintain accurate records of licenses, registrations, approvals, and expiry dates.
• Ensure ongoing compliance of products throughout their lifecycle.

Commercial & Business Support

• Provide regulatory support for tenders, technical evaluations, and health technology assessments.
• Support commercial teams, distributors, and business stakeholders on regulatory matters.
• Assist with product launch activities and market entry initiatives.
• Respond to regulatory enquiries from internal and external stakeholders.

Compliance, Quality & Vigilance

• Ensure compliance with applicable regulatory, vigilance, post-market surveillance, complaint handling, and recall requirements.
• Support Quality Management System (QMS) activities and regulatory SOP implementation.
• Collaborate with Quality and Safety teams on product-related incident reporting and field actions.
• Support regulatory inspections, audits, and authority interactions.

Stakeholder Engagement & Training

• Build strong relationships with regulatory authorities, ministries of health, distributors, and industry associations.
• Deliver regulatory guidance and training to associates, distributors, and business partners.
• Collaborate closely with cross-functional teams including Quality, Medical Affairs, Marketing, Supply Chain, and Commercial functions.

Minimum Requirements

Education

Bachelor's Degree in:

• Pharmacy
• Life Sciences
• Biomedical Sciences
• Relevant and updated licenses and Registrations

Experience

Minimum 3 years' Regulatory Affairs experience within:

• Medical Devices
• In Vitro Diagnostics (IVD)
• Diagnostics
• Healthcare
• Pharmaceutical industries
• Proven experience managing regulatory submissions and registrations.
• Experience working with East African regulatory authorities and regulatory frameworks.
• Exposure to vigilance, post-market surveillance, and quality systems would be advantageous.

Knowledge & Skills

• Strong understanding of medical device and IVD regulatory frameworks across East Africa.
• Knowledge of product registration processes and lifecycle management.
• Understanding of quality management systems and vigilance requirements.
• Excellent communication and stakeholder management skills.
• Strong project management and organizational ability.
• Ability to manage multiple projects and deadlines simultaneously.
• High attention to detail and commitment to compliance.
• Proficiency in Microsoft Office applications and regulatory management systems.
• Fluent English communication skills.

Ideal Candidate Profile

The successful candidate will be a proactive regulatory professional who can confidently engage with health authorities, support business growth through effective regulatory planning, and ensure products remain compliant throughout their lifecycle. You will possess strong analytical skills, commercial awareness, and the ability to work effectively across multiple countries and stakeholder groups.

• Develop and execute regulatory strategies for diagnostic products across East African markets.
• Monitor regulatory changes, legislation, and evolving market requirements.
• Support regulatory advocacy initiatives and engage with health authorities and industry stakeholders.
• Contribute to healthcare policy discussions and regulatory convergence initiatives.
• Prepare, compile, and submit regulatory dossiers and registration applications.
• Manage registration approvals, renewals, variations, and product maintenance activities.
• Maintain accurate records of licenses, registrations, approvals, and expiry dates.
• Ensure ongoing compliance of products throughout their lifecycle.
• Provide regulatory support for tenders, technical evaluations, and health technology assessments.
• Support commercial teams, distributors, and business stakeholders on regulatory matters.
• Assist with product launch activities and market entry initiatives.
• Respond to regulatory enquiries from internal and external stakeholders.
• Ensure compliance with applicable regulatory, vigilance, post-market surveillance, complaint handling, and recall requirements.
• Support Quality Management System (QMS) activities and regulatory SOP implementation.
• Collaborate with Quality and Safety teams on product-related incident reporting and field actions.
• Support regulatory inspections, audits, and authority interactions.
• Build strong relationships with regulatory authorities, ministries of health, distributors, and industry associations.
• Deliver regulatory guidance and training to associates, distributors, and business partners.
• Collaborate closely with cross-functional teams including Quality, Medical Affairs, Marketing, Supply Chain, and Commercial functions.

• Strong understanding of medical device and IVD regulatory frameworks across East Africa.
• Knowledge of product registration processes and lifecycle management.
• Understanding of quality management systems and vigilance requirements.
• Excellent communication and stakeholder management skills.
• Strong project management and organizational ability.
• Ability to manage multiple projects and deadlines simultaneously.
• High attention to detail and commitment to compliance.
• Proficiency in Microsoft Office applications and regulatory management systems.
• Fluent English communication skills.

• Bachelor's Degree in Pharmacy, Life Sciences, or Biomedical Sciences
• Relevant and updated licenses and Registrations
• Minimum 3 years' Regulatory Affairs experience within Medical Devices, In Vitro Diagnostics (IVD), Diagnostics, Healthcare, or Pharmaceutical industries
• Proven experience managing regulatory submissions and registrations.
• Experience working with East African regulatory authorities and regulatory frameworks.
• Exposure to vigilance, post-market surveillance, and quality systems would be advantageous.