Senior Regulatory Affairs Specialist – Africa (French Speaking)

About the role

Danaher Diagnostics is looking for a Regulatory Affairs Specialist for its African markets, fluent in French and English, on a 12-month remote contract. The role supports regulatory submissions, product registrations and market expansion activities across African countries.

Key responsibilities

• 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 obtain product approvals
• Maintain accurate regulatory documentation, approval records and certificates such as Certificates of Free Sale
• Collaborate with global and regional regulatory teams, Quality, Manufacturing, Sales and Marketing; conduct regulatory change assessments
• Support regulatory registration plans, identify product classifications and pathways, and gather regulatory intelligence
• Provide regulatory input to new product development and market expansion, and support project planning
• Maintain submission files, track KPIs and on-time delivery, and identify risks and process improvements

Required profile

• Bachelor's degree in Pharmacy, Biomedical Science, Life Sciences, Biotechnology, Chemistry or a related scientific discipline
• Previous regulatory affairs experience in medical devices, in-vitro diagnostics, healthcare or life sciences
• Hands-on experience preparing submissions, registrations, renewals and regulatory responses
• Knowledge of regulatory requirements in African countries, especially Francophone markets
• Fluent written and spoken French, strong professional English; additional African languages are an advantage

Required skills

• Familiarity with medical device and IVD regulatory frameworks and international standards
• Experience with regional regulatory authorities and cross-functional global teams
• Preferred: experience with diagnostics products, registrations across multiple African markets, ISO 13485, IVD regulations and regulatory change control

What we offer

• A global working environment with experienced regulatory colleagues
• Continuous improvement through the Danaher Business System, professional development and career growth