P2 - Specialist, Commercial Quality and Regulatory Affairs
Core
Support quality and regulatory processes including product registration, post-market vigilance, and quality audits for clinical diagnostics in the LATAM region.
Role type
Specialist, Commercial Quality and Regulatory Affairs
Builds
Regulatory compliance and quality assurance for diagnostic laboratory solutions
Domain
Life sciences / Clinical diagnostics / Medical devices
Required skills
Quality Management Systems, GMP regulation, Medical device regulations (LATAM), Product registration, Post-market vigilance, Technical documentation, Supplier audits, Distributor audits
Preferred skills
In vitro diagnostics knowledge, Cross-functional collaboration, Problem-solving
Technologies
Quality Management Systems, GMP
Responsibilities
Review and update Quality Management System alignment with sanitary regulations; Support warehouse GMP oversight and participate in internal/external audits; Prepare technical dossiers for product registration and license renewals; Evaluate design changes against regulatory requirements; Support sales channel partners with regulatory documentation.
Seniority
Specialist, individual contributor