Assoc Regulatory Affairs Spec-11.
Core
Support regulatory activities for medical devices across LATAM and APAC, focusing on documentation management, submissions, and compliance to enable product registrations and commercialization.
Role type
Associate Regulatory Affairs Specialist
Builds
Regulatory documentation packages and submissions for medical device product registrations
Domain
Medical devices / Healthcare technology
Required skills
Regulatory documentation management, Regulatory submissions preparation, Compliance monitoring, Stakeholder coordination, Document management systems proficiency, Labeling and protocol review
Preferred skills
Experience in regulated industries (medical devices, pharmaceuticals), Quality or Supply Chain background, Multitasking in remote environments
Technologies
Microsoft Office (Excel, Word, Outlook, PowerPoint), Document management systems
Responsibilities
Coordinate and prepare documentation packages for regulatory submissions, audits, and inspections; Compile documentation for license renewals and annual registrations; Review, organize, and maintain regulatory documentation across multiple systems; Support responses to regulatory agency requests; Partner with internal stakeholders and distributors to ensure timely completion of regulatory activities; Monitor documentation status and support compliance with regulatory requirements; Recommend changes to labeling, manufacturing, marketing, and clinical protocols to support compliance
Seniority
Junior, hands-on IC