Product Registration Specialist Full Time NEW

Job Summary

We are looking for a Product Registration Specialist to manage product registration processes, conduct market research, identify new product opportunities, and ensure product compliance. The role includes maintaining regulatory documents, following up on registrations and renewals, and supporting internal teams with regulatory requirements.

Job description:

Product Registration Management

• Prepare and compile product registration dossiers in accordance with regulatory authority requirements.
• Submit registration applications and follow up until approvals are obtained.
• Ensure full compliance with all technical and legal requirements.

Market Research & Product Development

• Identify and source new products aligned with the company’s activities (medical devices / consumables / laboratory services).
• Conduct regular market research to assess the needs of medical centers and laboratories.
• Analyze market gaps and propose commercially viable product opportunities.
• Initiate and manage the registration of new products based on market needs and company strategy.

International Partnerships & Agency Development

• Identify and approach international manufacturers to secure exclusive or semi-exclusive agency agreements.
• Communicate and negotiate with global suppliers to introduce their products into the local market.
• Build and maintain long-term relationships with manufacturers.
• Follow up on agency agreements and contractual arrangements.

Regulatory Coordination

• Liaise with the Ministry of Health and other regulatory authorities.
• Respond to inquiries and comments related to registration files.
• Monitor and stay updated on regulatory changes and requirements.

Documentation Management

• Organize and maintain all registration-related documents (Certificates, Technical Files, etc.).
• Ensure timely renewal of licenses and registrations.
• Maintain an updated database of registered products.

Internal Coordination

• Collaborate with technical, procurement, and sales teams to ensure product compliance.
• Review product specifications prior to submission.

Compliance & Quality

• Ensure products comply with international standards (ISO, CE, FDA where applicable).
• Monitor regulatory updates and ensure company compliance.

Required Skills & Qualifications

• Bachelor’s degree in a related field.
• Experience in product registration, regulatory affairs, or market research.
• Knowledge of Ministry of Health regulations and registration procedures.
• Familiarity with ISO, CE, and FDA standards.
• Strong organizational and communication skills.
• Ability to analyze market needs and identify product opportunities.
• Ability to manage documents and follow up on deadlines.