Senior Commercial Quality Assurance Specialist – French Speaking

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🔥 8 minutes ago

🌐 Senegal, Morocco – Remote

🇸🇳 Senegal – Remote 🇲🇦 Morocco – Remote

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 10%

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Danaher Corporation

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Danaher Corporation is a leading global life sciences and diagnostics innovator that develops and supplies instruments, technologies, software, and services to accelerate scientific research, biotechnology development, and clinical diagnostics. The company operates through businesses focused on biotechnology tools, diagnostics platforms, and life sciences products, leveraging the Danaher Business System and an acquisition-driven strategy to scale technologies and support customers across academia, pharmaceutical and biotech companies, and clinical laboratories.

📋 Description

• 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 • Coordinate with local regulatory representatives and health authorities to facilitate product registrations and approvals • Ensure timely delivery of regulatory activities supporting product launches and business priorities • Maintain regulatory documentation, product approvals, registration records and certificates, including Certificates of Free Sale • Collaborate with global and regional Regulatory Affairs teams, Quality, Manufacturing, Sales and Marketing • Conduct regulatory change assessments for product design, manufacturing, labeling, packaging and other relevant changes • Support compliance with applicable regulatory requirements across African markets • Resolve registration challenges and accelerate pending approvals with global regulatory stakeholders • Develop and execute regulatory registration plans aligned with business priorities • Identify product classifications, registration pathways and country-specific regulatory requirements • Gather and share regulatory intelligence across African markets • Provide regulatory input to new product development and market expansion initiatives • Support regulatory project planning, including milestones, deliverables and timelines • Monitor registration progress, KPIs and on-time delivery of regulatory deliverables • Identify regulatory risks, submission delays and process improvement opportunities • Apply continuous improvement principles to enhance regulatory processes and efficiency

🎯 Requirements

• 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 regulatory requirements and 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 • Fluent proficiency in written and spoken French is required • Strong professional proficiency in written and spoken English is required • Additional African languages are an advantage • Preferred: experience with diagnostics products, including assays, laboratory instruments and associated software • Preferred: previous responsibility for regulatory registrations across multiple African markets • Preferred: experience supporting product launches or market expansion projects in Francophone Africa • Preferred: familiarity with ISO 13485, applicable IVD regulations and regulatory change control processes • Preferred: experience working within a multinational medical technology or diagnostics organization

🏖️ Benefits

• Professional development • Meaningful career growth • Opportunity to work in a global environment • Collaboration with experienced regulatory professionals • Continuous improvement through the Danaher Business System (DBS)

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