Senior Commercial Quality Assurance Specialist - French Speaking - 12 Month Cont

Writing Regulatory Affairs Specialist – Africa (French Speaking) 12 Month Contract Company: Danaher Diagnostics Location: Remote Language Requirement: Fluent French and English Region: Africa About Danaher Diagnostics At Danaher , we are dedicated to advancing science and technology to improve human health. Our Diagnostics businesses provide innovative diagnostic solutions that help healthcare professionals make faster, more accurate decisions and improve patient outcomes. We are looking for a Regulatory Affairs Specialist – Africa (French Speaking) 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 from regulatory authorities. 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, product approvals, registration records and relevant certificates, including Certificates of Free Sale (CFS). Regulatory Compliance & Cross-Functional Collaboration Collaborate with global and regional Regulatory Affairs teams, Quality, Manufacturing, Sales and Marketing to support regulatory activities. Conduct regulatory change assessments for product design, manufacturing, labeling, packaging and other relevant changes. Support compliance with applicable regulatory requirements across African markets. Work closely 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 applicable product classifications, registration pathways and country-specific regulatory requirements. Gather and share regulatory intelligence, including changes in regulatory requirements across African markets. Provide regulatory input to new product development and market expansion initiatives. Support regulatory project planning, including milestones, deliverables and...

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