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