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 regulatory activities across the EMEA region, focusing on North Africa. The role involves managing product registrations, change control, and ensuring compliance within the medical diagnostics industry.

Key responsibilities

• Support development and execution of 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 regulatory documentation.
• Support product registrations, amendments, and maintenance of existing regulatory approvals and certificates.
• Maintain regulatory databases, track submission status, and report milestones using defined KPIs.
• Provide backup for local Regulatory Affairs activities as needed.
• Represent Regulatory Affairs in project meetings, IVDR and change‑control forums.
• Monitor regulatory developments, legislation, and industry standards in supported markets.
• Conduct regulatory impact assessments and communicate changes to internal stakeholders.

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 local Ministry of Health requirements in North Africa.
• Experience with regulatory submissions, registrations, and change‑management activities.
• Excellent verbal and written communication skills 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 within cross‑functional and multicultural teams.
• Working knowledge of local regulatory requirements, industry standards, and guidance documents.