Quality & Regulatory Affairs Specialist
Core
Manage product registration and regulatory documentation to ensure compliance with current regulations and support registration processes with competent authorities.
Role type
Quality & Regulatory Affairs Specialist
Builds
Regulatory compliance and product registration dossiers
Domain
Medical devices / Healthcare
Required skills
Knowledge of Ministry of Health registration procedures, Quality Assurance experience, ISO management system knowledge, Regulatory compliance knowledge, Organizational precision, Microsoft Office proficiency
Preferred skills
Degree in CTF, Pharmacy, Biology, Chemistry or related fields
Responsibilities
Manage product registration activities according to current regulations; Prepare and update regulatory documentation; Manage registrations and compliance on the Ministry of Health portal; Support quality management system activities and ISO certifications; Collaborate with internal departments to ensure regulatory and documentation compliance; Monitor regulatory updates and integrate them into company documentation.