Regulatory Affairs & Product Registration Consultant / Manager

Regulatory Affairs & Product Registration Consultant / Manager

Tecolab is an ISO 17025 accredited laboratory specializing in microbiological efficacy and toxicology testing . As part of our growth, we are expanding our services to include product registration consultation for pharmaceutical, medical device, and cosmetic products — both locally (MDA, NPRA) and internationally (CE Mark, ISO 13485, GDPMD).

We are looking for an experienced and motivated Regulatory Affairs professional to lead and develop this new business unit.

Key Responsibilities

• Lead and manage product registration projects for pharmaceuticals, medical devices, and cosmetics with MDA and NPRA .
• Assist clients in obtaining CE Mark certification , including preparation of technical documentation and clinical evaluation reports (CER) .
• Develop, implement, and maintain ISO 13485 and GDPMD quality management systems for clients.
• Liaise with regulatory authorities, notified bodies, and clients to ensure compliance and timely approvals.
• Provide consultation on product classification, regulatory strategy, and dossier preparation.
• Identify business opportunities and contribute to business development in regulatory and compliance services.
• Collaborate closely with internal laboratory and project teams to support client needs.

Requirements

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