Senior Commercial Quality Assurance Specialist - French Speaking (12-Month Contract)

About the role

Danaher Diagnostics is looking for a Regulatory Affairs Specialist (French speaking) to support regulatory submissions, product registrations and market expansion across African markets. The position is remote, requires fluent French and English, and is offered as a 12-month contract.

Key responsibilities

• 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, including medium- to high-complexity projects.
• Coordinate with local regulatory representatives and health authorities to obtain product approvals.
• Maintain accurate regulatory documentation, approval records and certificates, including Certificates of Free Sale (CFS).
• Collaborate with global and regional regulatory teams, Quality, Manufacturing, Sales and Marketing; conduct regulatory change assessments for design, manufacturing, labeling and packaging.
• Support regulatory registration plans, identify product classifications and pathways, and gather regulatory intelligence.
• Provide regulatory input to new product development and market expansion, and support project planning with milestones and timelines.
• Maintain submission files, monitor KPIs and on-time delivery, and identify risks and opportunities for process improvement.

Required profile

• Bachelor's degree in Pharmacy, Biomedical Science, Life Sciences, Biotechnology, Chemistry or a related scientific discipline.
• Previous regulatory affairs experience in medical devices, in-vitro diagnostics (IVD), healthcare or life sciences.
• Hands-on experience preparing regulatory submissions, registrations, renewals and regulatory responses.
• Knowledge of regulatory requirements across African countries, especially Francophone markets.
• Fluent written and spoken French, and strong professional written and spoken English; additional African languages are an advantage.
• Ability to manage multiple regulatory projects and deadlines in a fast-paced international environment.

Required skills

• Familiarity with medical device and IVD regulatory frameworks and international standards.
• Experience with regional regulatory authorities and cross-functional global teams.
• Preferred: experience with diagnostics products, registrations across multiple African markets, product launches in Francophone Africa, ISO 13485, IVD regulations and regulatory change control.

What we offer

• A global working environment with experienced regulatory professionals.
• Continuous improvement through the Danaher Business System (DBS), professional development and career growth.