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.

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