Hiring: Freelance Regulatory Affairs Specialist (Medical Devices – Africa Region)We are looking for an experienced Regulatory Affairs Consultant / Freelance Specialist on a contract basis to compile and manage product registration dossiers for our Class I Medical Device across multiple African countries.

Our product is already CE (MDR) and US FDA approved, and we have established local regulatory teams and agents present in African countries. Your core role will be compiling the dossier packages, liaising with the manufacturer, and coordinating directly with our local teams to ensure seamless submissions.

Key Responsibilities

- Dossier Compilation: Prepare and compile complete registration documentation packages (CE MDR, US FDA docs, FSC, COA, ISO, IFU, labels) according to country-specific requirements across Africa.
- Manufacturer Coordination: Coordinate with the manufacturing team verify, and gather all technical documents, artwork, and certificates required for filing.
- Local Team Liaison: Work closely with our local regulatory agents/distributors in African countries,



handing over compiled dossiers and supporting them through the submission process.
- Timeline Tracking: Monitor submission progress, resolve documentation queries raised by local teams, and track approvals.

Key Qualifications & Requirements

- Domain Experience: Solid background in Regulatory Affairs for Medical Devices (Class I / Class II).
- Regional Knowledge: Experience preparing regulatory dossiers for African countries.
- Technical Understanding: Familiarity with CE MDR and US FDA product document structures.
- Communication Skills: Excellent coordination skills to bridge communication between the manufacturer and local African regulatory agents.

Engagement & Compensation

- Type: Freelance / Project-based / Short-term Contract

? How to Apply: If you have experience handling medical device documentation for African markets, please send a direct message or share your CV at [email protected]

📌 Medical device regulatory freelancer (Noida)
🏢 Vaancure Biologics
📍 Noida