Regulatory Affairs IVDR Contractor (North Africa)

About the role

iQVIA is seeking an experienced Regulatory Affairs IVDR contractor to support regulatory activities across the EMEA region, with a focus on In Vitro Diagnostic (IVD) transition projects, product registrations, regulatory compliance and change control in the medical diagnostics industry. The position is based in Algeria, Morocco or Tunisia and is remote or hybrid depending on the location.

Key responsibilities

• Support the development and execution of regulatory submission plans for IVDR transition projects across the EU.
• Collaborate with global Regulatory Affairs, Legal, Manufacturing, Supply Chain, Marketing and Commercial teams, as well as distributor markets.
• Manage change control projects by coordinating with manufacturing sites to obtain regulatory documentation and dossiers.
• Support product registrations and amendments to existing approvals and certificates.
• Maintain regulatory databases and escalate risks where necessary.
• Track, monitor and report submission status and regulatory milestones through KPIs and reporting platforms.
• Provide backup support for local Regulatory Affairs activities and represent Regulatory Affairs at project meetings, including IVDR and change control forums.
• Monitor regulatory developments, legislation and industry standards, conduct regulatory impact assessments and communicate changes internally.
• Support strategic Quality and Regulatory Affairs objectives and perform additional compliance duties as required.

Required profile

• At least 2 years of experience in Regulatory Affairs within the medical devices industry, preferably in IVDs.
• Demonstrated knowledge of the medical diagnostics industry and regulatory environments in the supported regions.
• Experience supporting regulatory submissions, registrations and change management.
• Currently based in Algeria, Morocco or Tunisia.
• Proactive, able to work independently and manage multiple priorities.

Required skills

• Working knowledge of local Ministry of Health regulations, regulatory requirements, industry standards and guidance documents.
• Excellent English; French is advantageous.
• Strong project management, analytical and problem-solving skills.
• Ability to work in cross-functional, multicultural teams and to handle confidential information discreetly.