[Hiring] Senior Commercial Quality Assurance Specialist @Danaher

Role Description

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

• 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).
• 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.
• 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.
• 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

• 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.

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.

Benefits

• Opportunity to work in a global environment and collaborate with experienced regulatory professionals.
• Support for the introduction of innovative diagnostic technologies into African healthcare markets.
• Commitment to continuous improvement through the Danaher Business System (DBS), professional development and meaningful career growth.