Sr. Regulatory Affairs Associate – CONSULTANT (EU MDR)

Location: Remote in Mexico

Company

hirify.global is a global full-service contract research organization providing clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies.

What you will do

• Review, create, and update technical documents in accordance with EU MDR and other applicable medical device regulations.
• Identify regulatory requirements, harmonized standards, guidance documents, and submission expectations.
• Compile technical file and design documentation into PDF packages, including bookmarks and indexes, and upload them to PLM systems through change orders.
• Perform quality control checks for document completeness, pagination, revisions, approvals, and missing or blank pages.
• Coordinate with cross-functional teams and local affiliates to obtain supporting documents and respond to regulatory inquiries.
• Represent Regulatory Affairs on project teams, communicate project status, and support additional regulatory activities.

Requirements

• Bachelor’s degree; a life sciences background is preferred.
• At least 2 years of Regulatory Affairs experience focused on EU MDR.
• Mandatory knowledge of EU MDR, ISO 13485, and FDA medical device regulations.
• Working proficiency with Microsoft Office, including Word, Excel, and PowerPoint.
• Strong organization, attention to detail, planning, analysis, and communication skills.
• Strong written and verbal English communication skills are required.

Culture & Benefits

• 12-month consultant contract with the possibility of extension.
• Direct client-facing work supported by a global CRO environment.
• Professional development, continuous training, and supportive management.
• Work with international teams across the Americas, Europe, and Asia-Pacific.

Hiring process

• Submit a CV and receive an application acknowledgement.
• Qualified candidates are invited to a phone interview as the first step.