Insulet is committed to enabling customers to enjoy simplicity, freedom, and healthier lives through innovative wearable medical device technology
Job Summary
Insulet is committed to enabling customers to enjoy simplicity, freedom, and healthier lives through innovative wearable medical device technology.
The Supervisor leads a team to maintain document integrity, security, and accessibility while ensuring compliance with regulatory requirements and driving process improvements.
This role fosters a collaborative, customer-focused team environment emphasizing accuracy, accountability, and strong internal service.
Matching Summary
Insulet is committed to enabling customers to enjoy simplicity, freedom, and healthier lives through innovative wearable medical device technology.
Skills & Requirements
Must-have
Document and records control
Quality Management System compliance
FDA 21 CFR Part 820 knowledge
ISO 13485 quality standards
Document change management
Team supervision and development
Continuous improvement initiatives
Nice-to-have
Electronic document control systems
Strong verbal and written communication
Cross-functional collaboration
Customer-service mindset
Task management and prioritization
Positive team environment
Key Requirements
PA or Bachelor's degree or equivalent experience
Minimum 7 years regulated industry experience
3+ years in Quality Assurance, Regulatory Affairs, or Document Control
3+ years supervisory experience
Working knowledge of FDA 21 CFR Part 820 and ISO 13485