Sr. Regulatory Affairs Associate – CONSULTANT (EU MDR)

Location: Canada; remote

Salary: $40–$44 CAD

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 applicable global medical device regulatory requirements.
• Identify relevant regulations, harmonized standards, guidance documents, and submission expectations.
• Compile technical file and design documentation from PLM or similar sources into indexed and bookmarked PDF files.
• Perform quality control checks for document completeness, pagination, current revisions, approvals, and missing or blank pages.
• Coordinate with cross-functional teams, local affiliates, regulatory management, and project teams on supporting documentation and health authority inquiries.
• Report regulatory requirements, project status, and deliverables, and support additional regulatory activities as assigned.

Requirements

• Bachelor’s degree, preferably in life sciences.
• 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 in Microsoft Word, Excel, and PowerPoint.
• Strong organizational, planning, analytical, written, and verbal communication skills.
• Strong written and verbal English communication skills are required.

Culture & Benefits

• 12-month consultant contract with the possibility of extension.
• Work directly with a single sponsor while receiving the support and career opportunities of a global CRO.
• Client-facing work with opportunities for independent ownership and cross-functional collaboration.
• Professional development, continuous training, and a supportive, inclusive culture.
• AI screening is used during recruitment, with recruiter review of results.

Hiring process

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