Regulatory Affairs IVDR - Contractor Côte d'Ivoire

External Job Description
Regulatory Affairs IVDR Contractor – Côte d'Ivoire (Ivory Coast)

Location: Côte d'Ivoire (Ivory Coast)
Contract Type: Contractor

About the Opportunity

We are seeking an experienced Regulatory Affairs IVDR Contractor to support regulatory activities across the EMEA region, with a key focus on In Vitro Diagnostic Regulation (IVDR) transition projects, product registrations, regulatory compliance, import notification applications, and change control activities within the medical diagnostics industry.

This is an exciting opportunity for a regulatory professional with experience in medical devices, ideally IVDs, who thrives in a fast-paced, cross-functional environment and is passionate about ensuring regulatory compliance while supporting business objectives.

Key Responsibilities

• Support the development and execution of regulatory submission plans related to IVDR transition projects across the EU region.
• Collaborate with global Regulatory Affairs teams, Legal, Manufacturing, Supply Chain, Marketing, Commercial teams, and distributor markets to support regulatory initiatives.
• Manage and support applicable change control projects by coordinating with manufacturing sites and relevant stakeholders to obtain regulatory documentation and dossiers.
• Support product registrations, import notification request applications, and amendments to existing regulatory approvals and certificates.
• Maintain regulatory databases and proactively escalate risks where necessary.
• Track, monitor, and report submission status and regulatory milestones through defined KPIs and reporting platforms.
• Provide backup support for local Regulatory Affairs activities when required.
• Represent Regulatory Affairs at project meetings, including IVDR and change control forums.
• Monitor regulatory developments, legislation, and industry standards within supported markets.
• Conduct regulatory impact assessments and communicate relevant changes to internal stakeholders.
• Support strategic Quality and Regulatory Affairs objectives.
• Perform additional regulatory and compliance-related duties as required.

Minimum Requirements

Education & Experience

• Minimum of 2 years' experience in Regulatory Affairs within the Medical Devices industry, preferably in In Vitro Diagnostics (IVDs).
• Demonstrated knowledge of the medical diagnostics industry and regulatory environments within supported regions.
• Experience supporting regulatory submissions, registrations, import notification applications, and change management activities.