Description

You will manage medical device license applications and regulatory compliance across global markets.

Responsibilities

• Prepare and submit medical device license and registration applications to Health Canada, FDA, and other international agencies.
• Coordinate with supervisors, local representatives, and distributors to compile submissions and respond to agency queries.
• Manage the lifecycle of registrations, including renewals, device listings, site registrations, and annual updates.
• Monitor international regulations and standards to ensure product compliance.
• Research regulatory issues and communicate findings to Production, QA/QC, R&D, and senior management.

Required Skills

• 5+ years of experience in regulatory affairs.
• Experience managing submissions for Health Canada and FDA.
• Knowledge of GMP and GLP standards.
• Experience working with SOPs.
• Proficiency in Adobe Acrobat.
• Ability to maintain and update global device registrations and licenses.
• Any graduate degree.

Key Skills

Education

ANY GRADUATE