Post Market Surveillance Analyst - Remote

Overview

The Post Market Surveillance Analyst plays a crucial role in ensuring the quality and compliance of complaint records within Juul Labs' Quality Management System, supporting the overall operational integrity.

In Short

• Monitor and assess the quality of complaint records for compliance.
• Responsible for daily workflow reports to ensure timely complaint processing.
• Manage corrections of non-conforming complaint files.
• Ensure compliance with regulatory reporting timelines.
• Facilitate collaboration across internal departments for process improvements.
• Stay updated on local and global regulations related to post-market surveillance.
• Act as a Subject Matter Expert during audits.
• Coordinate projects and provide operational support.

Requirements

• 3-5+ years of experience in quality, manufacturing, or regulatory fields.
• Strong critical thinking and investigation skills.
• Ability to derive data from enterprise systems.
• Strong analytical and project management skills.
• Understanding of FDA regulations and ISO Standards.
• Well organized with the ability to manage multiple initiatives.
• Excellent verbal and written communication skills.
• Knowledge of quality management system concepts.
• Ability to influence and drive change.
• Prior experience in complaint handling in medical devices or pharma.

Benefits

• Career growth opportunities.
• Supportive team environment.
• Equity and performance bonuses.
• Comprehensive medical, dental, and vision insurance.
• 401(k) plan with company matching.
• Discretionary performance bonuses.