Regulatory Affairs IVDR Contractor

Job title: Regulatory Affairs IVDR Contractor

About the Role IQVIA is seeking an experienced Regulatory Affairs IVDR Contractor to support regulatory activities across the EMEA region, with a key focus on IVDR transition projects, product registrations, regulatory compliance, import notification applications, and change control activities within the medical diagnostics industry. This role is based in Côte d'Ivoire (Ivory Coast) and involves field-based work supporting cross-functional teams to ensure regulatory compliance while enabling business objectives.

What You'll Do

• Develop and execute regulatory submission plans related to IVDR transition projects across the EU region.
• Collaborate with global Regulatory Affairs teams, Legal, Manufacturing, Supply Chain, Marketing, Commercial teams, and distributor markets to support regulatory initiatives.
• Manage and support applicable change control projects by coordinating with manufacturing sites and relevant stakeholders to obtain regulatory documentation and dossiers.
• Support product registrations, import notification requests, and amendments to existing regulatory approvals and certificates.
• Maintain regulatory databases and proactively escalate risks; track, monitor, and report submission status and regulatory milestones through defined KPIs and reporting platforms.
• Provide backup support for local Regulatory Affairs activities when required.
• Represent Regulatory Affairs at project meetings, including IVDR and change control forums.
• Monitor regulatory developments, legislation, and industry standards within supported markets.
• Conduct regulatory impact assessments and communicate relevant changes to internal stakeholders.
• Support strategic Quality and Regulatory Affairs objectives.
• Perform additional regulatory and compliance-related duties as required.

What We're Looking For

• Minimum of 2 years' experience in Regulatory Affairs within the Medical Devices industry, preferably in In Vitro Diagnostics (IVDs).
• Demonstrated knowledge of the medical diagnostics industry and regulatory environments within supported regions.
• Experience supporting regulatory submissions, registrations, import notification applications, and change management activities.
• Strong project management capabilities.
• Ability to work effectively within cross-functional and multicultural teams.
• Working knowledge of local Ministry of Health regulations, regulatory requirements, industry standards, and guidance documents.
• Fluent verbal and written English is mandatory.

Nice to Have

• None specified in the posting.

Compensation & Benefits

• No salary range, benefits, or perks are specified in the posting.