Regulatory Affairs IVDR Contractor – North Africa

About the role

We are looking for an experienced Regulatory Affairs IVDR Contractor to support regulatory activities across the EMEA region, focusing on In Vitro Diagnostic Regulation (IVDR) transition projects, product registrations, and change control. The role is remote/hybrid and serves the North African market.

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 regulatory documentation.
• Support product registrations and amendments to existing approvals and certificates.
• Maintain regulatory databases and proactively flag risks.
• Track, monitor and report submission status and milestones using defined KPIs.
• Provide backup for local Regulatory Affairs activities as needed.
• Represent Regulatory Affairs in project meetings and IVDR forums.
• Monitor regulatory developments, legislation and industry standards in supported markets.
• Conduct regulatory impact assessments and communicate changes to stakeholders.
• Support strategic Quality and Regulatory Affairs objectives and perform additional compliance duties.

Required profile

• Minimum 2 years of Regulatory Affairs experience in the Medical Devices industry, preferably In Vitro Diagnostics.
• Demonstrated knowledge of medical diagnostics regulatory environments in the supported regions.
• Experience with regulatory submissions, registrations and change‑management activities.

Required skills

• Strong project‑management capabilities.
• Working knowledge of local Ministry of Health regulations, industry standards and guidance documents.
• Excellent verbal and written communication in English; French is advantageous.
• High attention to detail, professionalism and ability to handle confidential information.