Senior Commercial Quality Assurance Specialist - French Speaking - 12 Month Contract
Danaher · MA
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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 timelines.
Reporting & Documentation
- Maintain organized and accurate regulatory submission files, correspondence, approvals and certificates.
- Monitor registration progress, key performance indicators (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 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.
Language Requirements
- French: Fluent proficiency in written and spoken French is required, including the ability to communicate with regulatory authorities and review 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
At Danaher, you'll have the opportunity to work in a global environment, collaborate with experienced regulatory professionals and support the introduction of innovative diagnostic technologies into African healthcare markets.
You will also benefit from our commitment to continuous improvement through the Danaher Business System (DBS), professional development and meaningful career growth.
Join Danaher Diagnostics and help bring life-changing diagnostic technologies to more patients across Africa.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.