Regulatory Affairs Specialist – Africa (French Speaking) – 12 Month Contract

Regulatory Affairs Specialist – Africa (French Speaking)

Contract: 12 months
Location: Remote
Region: Africa
Language requirement: Fluent French and English

About the Role

Danaher Diagnostics is looking for a Regulatory Affairs Specialist to support regulatory submissions, product registrations and market expansion activities across African markets.

Key Responsibilities

Regulatory Submissions & Product Registrations

• Prepare and manage regulatory submissions for African countries, including initial registrations, renewals, variations and responses to additional information requests.
• Support market expansion registrations for diagnostic assays, instruments and software, including medium- to high-complexity projects.
• Coordinate with local regulatory representatives and health authorities to facilitate product registrations and approvals.
• Ensure timely delivery of regulatory activities to support product launches and business priorities.
• Maintain accurate regulatory documentation, approvals, registration records and Certificates of Free Sale (CFS).

Regulatory Compliance & Cross-Functional Collaboration

• Collaborate with global and regional Regulatory Affairs, Quality, Manufacturing, Sales and Marketing teams.
• Conduct regulatory change assessments for product design, manufacturing, labeling, packaging and other relevant changes.
• Support compliance with applicable regulatory requirements across African markets.
• Work with global regulatory stakeholders to resolve registration challenges and accelerate pending approvals.

Regulatory Strategy & Market Expansion

• Support the development and execution of regulatory registration plans aligned with business priorities.
• Identify product classifications, registration pathways and country-specific regulatory requirements.
• Gather and share regulatory intelligence, including changes in requirements across African markets.
• Provide regulatory input to new product development and market expansion initiatives.
• Support regulatory project planning, including milestones, deliverables and timelines.

Reporting & Documentation

• Maintain organized and accurate regulatory submission files, correspondence, approvals and certificates.
• Monitor registration progress, KPIs and on-time delivery of regulatory deliverables.
• Identify regulatory risks, submission delays and opportunities for process improvement.
• Apply continuous improvement principles to enhance regulatory processes and efficiency.

Qualifications & Experience

• Bachelor's degree in Pharmacy, Biomedical Science, Life Sciences, Biotechnology, Chemistry or a related scientific discipline.
• Previous experience in Regulatory Affairs within medical devices, in-vitro diagnostics (IVD), healthcare or life sciences.
• Hands-on experience preparing regulatory submissions, product registrations, renewals and regulatory responses.
• Knowledge of registration processes across African countries, particularly Francophone African markets.
• Familiarity with medical device and IVD regulatory frameworks and international standards.
• Experience working with regional regulatory authorities and cross-functional global teams.
• Strong organizational, communication and stakeholder management skills.
• Ability to manage multiple regulatory projects and deadlines in a fast-paced international environment.

Language Requirements

• French: Fluent proficiency in written and spoken French is required, including communicating with regulatory authorities and reviewing regulatory documentation.
• English: Strong professional proficiency in written and spoken English is required.
• Additional African languages are an advantage.

Preferred Qualifications

• Experience with diagnostics products, including assays, laboratory instruments and associated software.
• Previous responsibility for regulatory registrations across multiple African markets.
• Experience supporting product launches or market expansion projects in Francophone Africa.
• Familiarity with ISO 13485, applicable IVD regulations and regulatory change control processes.
• Experience working within a multinational medical technology or diagnostics organization.

What We Offer

Work in a global environment alongside experienced regulatory professionals, supporting the introduction of innovative diagnostic technologies into African healthcare markets.

Benefit from continuous improvement through the Danaher Business System (DBS), professional development and meaningful career growth.