Job Category: Administration
Job Type: Full Time
Job Location: Austin TX

EDAP is a global leader in high-tech robotic medical devices for the diagnosis and treatment of Prostate Cancer. EDAP is a NASDAQ-listed international group with a rapid growing presence in the United States, leading with the proprietary Focal One technology brand ( We are seeking a talented professional individual to join our fast-growing operation as Director of Regulatory Affairs and Quality Assurance. This essential member of EDAP’s US Team must be capable of leading the US Regulatory Strategy into expanding the clinical indication of its FDA-Cleared Focal One Robotic HIFU (High Intensity Focused Ultrasound) platform to the treatment of deep-infiltrating rectal endometriosis. This individual will provide oversight of EDAP’s US Quality System as to maintain compliance within corporate guidelines.

Core competencies of the RAQA Director will be prior success with gathering FDA market authorization via PMA, de Novo and/or 510(k) processes for medical devices, ideally in OB/GYN and urology applications.

Key Responsibilities

· Serves as the company’s Management Representative

· Designs and executes the Regulatory Strategy for FDA approval or clearance of new devices or indications

· Maintains and improves organizational post market surveillance and provides oversight of the vigilance system in collaboration with other members of management to insure effectiveness

· Supports and manages regulatory audits, audit preparedness and readiness profiles

· Manages the inspection, testing, and evaluation of product quality and performance

· Writes training materials and conducts Quality and Regulatory System training for company personnel

· Maintains current knowledge and compliance with the full range of related quality systems, including regulatory requirements and related policies and procedures

· Performs other related duties as assigned by management or as required

Professional Experience/Qualifications

· Has successfully conducted the domestic clearance of class II and/or class III medical devices

· Understands the various FDA Regulatory pathways

· Has experience in submitting formal applications and interacting with FDA teams

· Provides management and execution of Post Market Surveillance for domestic markets

· Demonstrates prior experience managing systems and processes for efficient vigilance reporting in the US

· Possesses a hands-on entrepreneurial mind with the ability to work effectively in a dynamic professional environment

· Has the ability to meet deadlines with good time-management skills

· Exercises excellent interpersonal and customer service skills, with the ability to communicate effectively verbally and in writing to individuals at all levels

· Demonstrates the ability to manage through distractions, perform with changing priorities and aggressive deadlines


· Bachelor’s Degree 

· Minimum of 8 years in the medical device industry or related GMP environment or equivalent, 4 years of which responsible for leading the Regulatory function

· Experience with Class II and/or III medical devices/ systems

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