Regulatory Affairs IVDR Contractor – Côte d'Ivoire

About the role

We are looking for an experienced Regulatory Affairs IVDR Contractor to support our regulatory activities across the EMEA region, focusing on In Vitro Diagnostic Regulation (IVDR) transition projects, product registrations and compliance in the medical diagnostics sector. The role is based in Côte d'Ivoire and will work closely with cross‑functional teams to ensure timely regulatory submissions and maintain compliance.

Key responsibilities

• Develop and execute regulatory submission plans for IVDR transition projects across the EU.
• Collaborate with global Regulatory Affairs, Legal, Manufacturing, Supply Chain, Marketing, Commercial teams and distributors.
• Manage change‑control projects, coordinating with manufacturing sites to obtain required documentation.
• Support product registrations, import notification applications and amendments to existing approvals.
• Maintain regulatory databases, track milestones and report status via KPIs.
• Provide backup for local Regulatory Affairs activities as needed.
• Represent Regulatory Affairs in project meetings and IVDR forums.
• Monitor regulatory developments and conduct impact assessments.

Required profile

• Minimum 2 years of Regulatory Affairs experience in the Medical Devices industry, preferably In Vitro Diagnostics.
• Strong knowledge of medical diagnostics regulations and the IVDR framework.
• Fluent verbal and written English; ability to manage documentation in English.
• Experience supporting regulatory submissions, registrations, import notifications and change management.

Required skills

• Regulatory submissions
• IVDR compliance
• Medical device regulations
• Project management