Regulatory Affairs IVDR Contractor – North Africa

About the role

We are looking for an experienced Regulatory Affairs Contractor to lead IVDR transition projects and support product registrations across the EMEA region, with a focus on Algeria, Morocco, and Tunisia. The role is remote/hybrid and offers the chance to work in a fast‑paced, cross‑functional environment within the medical diagnostics industry.

Key responsibilities

• Develop and execute regulatory submission plans for IVDR transition projects in the EU.
• Collaborate with global Regulatory Affairs, Legal, Manufacturing, Supply Chain, Marketing, Commercial, and distributor teams.
• Coordinate change‑control projects, gather regulatory documentation, and maintain dossiers.
• Support product registrations, amendments, and certificate updates.
• Maintain regulatory databases, track milestones, and report KPIs.
• 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 sector, preferably In Vitro Diagnostics.
• Strong knowledge of local Ministry of Health regulations and EU IVDR requirements.
• Excellent written and verbal communication in English; French is a plus.
• High attention to detail, professionalism, and ability to handle confidential information.

Required skills

• Project management capabilities.
• Stakeholder management across multicultural teams.
• Analytical and problem‑solving abilities.