Medical device regulatory submissions require technical writing and compliance expertise at Wellnest. Support USA, Canada, and Europe submissions while managing regulatory requirements.
As a Regulatory Affairs Specialist, you will research, write, analyze, edit, and compile technical documents for country-specific submissions. You will communicate requirements across departments, support manufacturing processes, and address regulatory authority inquiries. The work includes device incidents, labels, promotional materials, audits, and applicable guidance.
Key Responsibilities: Research and compile technical regulatory submission documents
Support manufacturing process setup and model changes
Prepare responses to regulatory authority questions




Assess device incidents and submit reportable events
Review labels and promotional materials for compliance
Requirements: Two to five years of experience
Knowledge of manufacturing licensing and CDSCO
Experience with applicable ISO standards
Ability to lead startup regulatory processes independently
Medical device approval experience is an advantage
Apply regulatory writing, compliance, manufacturing, and incident assessment skills across Wellnest medical device submissions.

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📌 Medical Device Regulatory Affairs Specialist (Manitoba)
🏢 Wellnest Health Monitoring
📍 Manitoba