Description

You will manage quality compliance and regulatory requirements within a regulated industry environment.

Responsibilities

• Support post-market surveillance activities and regulatory audits.
• Manage compliance processes related to 21CFR 806 and Canada Recall Regulations.
• Oversee quality documentation and system integrity.

Required Skills

• 1-2 years of relevant experience in medical device, in vitro diagnostics, or pharmaceutical industries.
• BA or BS degree.
• Knowledge of regulatory standards for medical devices containing software.
• Familiarity with ERP systems.
• Familiarity with QMS systems.
• Understanding of post-market surveillance protocols.
• Knowledge of 21CFR 806 and Canada Recall Regulations.

Key Skills

Education

BA or BS degree