Senior Commercial Quality Assurance Specialist – French Speaking

This is a fully remote position, open to applicants in Senegal, +1 more country.

📋 Description

• Prepare and oversee regulatory submissions for African nations, encompassing initial registrations, renewals, variations, and responses to additional information requests.

• Assist in the registration processes for market expansion related to diagnostic assays, instruments, and software.

• Collaborate with local regulatory representatives and health authorities to streamline product registrations and approvals.

• Ensure that regulatory activities are delivered promptly to support product launches and align with business priorities.

• Maintain all regulatory documentation, including product approvals, registration records, and certificates, such as Certificates of Free Sale.

• Work in conjunction with global and regional Regulatory Affairs teams, Quality, Manufacturing, Sales, and Marketing departments.

• Conduct assessments of regulatory changes for product design, manufacturing, labeling, packaging, and other pertinent modifications.

• Ensure compliance with relevant regulatory requirements across African markets.

• Address registration challenges and expedite pending approvals with global regulatory stakeholders.

• Develop and implement regulatory registration strategies aligned with business goals.

• Identify product classifications, registration pathways, and specific regulatory requirements for each country.

• Collect and disseminate regulatory intelligence throughout African markets.

• Provide regulatory insights for new product development and market expansion efforts.

• Assist in regulatory project planning, including setting milestones, deliverables, and timelines.

• Track registration progress, KPIs, and ensure on-time delivery of regulatory outputs.

• Recognize regulatory risks, submission delays, and opportunities for process improvements.

• Apply continuous improvement principles to optimize regulatory processes and enhance efficiency.

⛳️ Requirements

• A Bachelor's degree in Pharmacy, Biomedical Science, Life Sciences, Biotechnology, Chemistry, or a related scientific field.

• Prior experience in Regulatory Affairs within medical devices, in-vitro diagnostics (IVD), healthcare, or life sciences sectors.

• Practical experience in preparing regulatory submissions, product registrations, renewals, and regulatory responses.

• Understanding of regulatory requirements and registration processes in various African countries, especially in Francophone African markets.

• Familiarity with medical device and IVD regulatory frameworks and international standards.

• Experience collaborating with regional regulatory authorities and cross-functional global teams.

• Excellent organizational, communication, and stakeholder management abilities.

• Capability to handle multiple regulatory projects and deadlines in a dynamic international setting.

• Fluent proficiency in both written and spoken French is mandatory.

• Strong professional proficiency in both written and spoken English is essential.

• Knowledge of additional African languages is a plus.

• Preferred: experience with diagnostics products, including assays, laboratory instruments, and related software.

• Preferred: previous involvement in regulatory registrations across various African markets.

• Preferred: experience in 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

• Opportunities for professional development.

• Meaningful career advancement.

• A chance to work in a global environment.

• Collaboration with seasoned regulatory professionals.

• Continuous improvement fostered through the Danaher Business System (DBS).