Regulatory Affairs Analyst (Temporary position) (Based in Ciudad de Mexico)
Core
Completes and maintains regulatory approvals and clearances for medical devices, prepares domestic and international product submissions, and develops routine process improvement initiatives.
Role type
Regulatory Affairs Analyst
Builds
Regulatory submissions, playbooks, and process improvements for medical device products
Domain
Medical Devices / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submissions preparation, regulatory strategy development, timeline tracking, document preparation for regulatory bodies, Edwards systems execution, process improvement initiatives
Preferred skills
Domestic and international product submission experience, Microsoft Office Suite proficiency, new product development systems knowledge
Technologies
Edwards systems, Microsoft Office Suite
Responsibilities
Completes and maintains regulatory approvals and clearances of assigned products, Create regulatory submissions/playbook under close supervision, Track timelines and document milestone achievements, Develop routine Regulatory Affairs process improvement initiatives, Execute all RA activities in Edwards systems, Prepare documents for submissions
Seniority
Individual Contributor, Analyst level