Senior Regulatory Affairs Specialist - Lingo (on-site)

Abbott seeks a Senior Regulatory Affairs Specialist to support commercialization of Lingo, a biosensing medical device, in the United States. The role involves providing regulatory guidance to cross-functional teams, managing submissions, and ensuring compliance with FDA requirements for Class II software devices.

Responsibilities

• Represent regulatory affairs on cross-functional teams and guide product lifecycle planning for Class II software devices
• Assess documentation acceptability for medical device submissions and communicate regulatory guidance
• Review labeling, advertising, and promotional materials for compliance; develop regulatory strategy with marketing
• Prepare regulatory applications and submissions to FDA; evaluate design and labeling changes for regulatory impact
• Lead development and review of regulatory standard operating procedures; ensure post-marketing compliance requirements

Requirements

• Bachelor's degree in technical discipline such as biology, chemistry, or medical technology
• Minimum 2 years regulatory experience or 2 years relevant industrial experience in quality or product development
• Experience with 510(k) or PMA submissions or Class I/II exempt software devices preferred
• Strong written, verbal, and organizational skills with ability to manage multiple priorities
• Knowledge of FDA Quality System Regulation and software medical device requirements
• Ability to work independently and solve complex problems with cross-functional teams