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 involves ensuring compliance with In Vitro Diagnostic Regulation (IVDR) while collaborating with cross‑functional teams in a fast‑paced environment.

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.
• Manage change‑control projects, coordinating with manufacturing sites to obtain required documentation.
• Support product registrations, amendments, and maintenance of regulatory certificates.
• Maintain regulatory databases, track milestones, and report status via defined KPIs.
• Provide backup for local Regulatory Affairs activities and represent the function in project meetings.
• Monitor regulatory developments, conduct impact assessments, and communicate changes to stakeholders.

Required profile

• Minimum 2 years of Regulatory Affairs experience in the medical devices industry, preferably in IVDs.
• 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.
• Ability to work effectively in cross‑functional, multicultural teams.