Regulatory Affairs IVDR Contractor (Abidjan, Ivory Coast)
iqvia · Abidjan
Description du poste
About the role
IQVIA is seeking 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, compliance, import notifications, and change control within the medical diagnostics industry.
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, import notification applications, and amendments to existing approvals.
- Maintain regulatory databases, track milestones, and report status through KPIs.
- Represent Regulatory Affairs in project meetings and monitor regulatory developments.
Required profile
- Minimum 2 years of Regulatory Affairs experience in the Medical Devices industry, preferably IVDs.
- Strong project management capabilities and ability to work in cross‑functional, multicultural teams.
- Fluent verbal and written English; French proficiency is advantageous.
- High attention to detail, professionalism, and ability to handle confidential information.
Required skills
- Working knowledge of local Ministry of Health regulations and industry standards.
- Ability to manage regulatory documentation and correspondence in English.
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iqvia
Abidjan
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