The Manager of Regulatory Affairs works with the VP Regulatory to ensure Lungpacer Medical Inc meets global regulatory requirements for the company’s novel, emerging transvenous diaphragm pacing therapy, prepares applicable device regulatory submissions (IDE/pre-Subs/PMA and international pre-market applications) in collaboration with regulatory, clinical and product development staff, and interfaces with regulatory authorities as needed. Assists with corporate US and international regulatory compliance activities. Responsibilities: - Assist in developing global regulatory approval strategies in coordination with the VP of Regulatory; - Manage international regulatory activities with CRO EU regulatory partner; - Initiate submissions-related projects teams and track and manage their deliverables for regulatory submissions; - Create submissions-related materials for international filings and manage translation process; - Provide strategic regulatory guidance for product development and clinical activities; - Write summary documentation for regulatory applications such as labeling, literature search summaries, safety and efficacy summaries, and technical summaries; - Plan, review, and approve required documents from various departments for filing to regulatory authorities including technical documentation, study protocols, investigator’s brochures, study reports and clinical evaluation reports; - Provide regulatory review for patient and physician directed materials including training materials, trial documentation and advertising and promotion materials to ensure compliance with the device labeling and regulatory requirements; - Manage communications and relationships with local authorities for specified projects; - Help to develop procedures for regulatory submissions and compliance activities for investigational and commercial processes; - Maintain up-to-date knowledge of regulatory requirements; and - Help to mentor junior regulatory personnel.
• Bachelor’s degree is required in scientific/health care field; • Minimum of 3 years in regulatory submissions experience; • Working knowledge of FDA regulations for medical devices; OUS experience a plus • Experience with investigational and pre-market submissions; PMA experience a plus • Strong verbal and written communication skills • Ability to organize and manage multiple priorities in a fast-paced environment • Ability to work independently and collaboratively • Strong interpersonal skills to interact across disciplines and individuals at all levels of the organization and with regulatory authorities.
Internal Number: RAM01
About Lungpacer Medical
Lungpacer Medical Inc. is developing a novel therapeutic solution for preserving or restoring the integrity and strength of the diaphragm muscle in critically ill patients who require mechanical ventilation.