Quality and Regulatory Manager

LEONI is looking for a motivated full time Q&R Manager to join our team in the Williamsburg, VA office. The ideal candidate is familiar with quality management systems ISO 13485, FDA 21 CFR 820, ITAR regulations, and ISO 9001 and leads regulatory activities for our medical devices line of business in the U.S., the EU and other regions. If you enjoy working with other professionals in a collaborative and solution-oriented culture, we encourage you to apply.

Tasks and Responsibilities:
• Maintain and further develop our quality management system
• Gain understanding of new regulations, perform gap assessment, and assist with updates to the quality manual, operating procedures and other documentation to ensure compliance
• Lead external audits by the Notified Body, by the FDA and other regulatory authorities, and by customers
• Assist with maintenance and creation of technical documentation for medical devices
• Prepare and submits FDA 510(k)-type product applications in the U.S., the EU, and other regions
• Manage product recalls of medical devices
• Perform clinical risk assessment and post-market surveillance
• Perform project management and other duties as assigned by superior

Qualifications:
• Minimum bachelor's degree in a scientific or engineering discipline
• Minimum 3-5 years of experience working in quality systems pertaining to ISO 13485, FDA 21 CFR 820, EU MDD/MDR
• Preferred: Certified ISO 13485 auditor and prior direct interaction with inspectors and auditors
• Preferred: Work experience with Class II medical devices and technical file submission
• Ability to legally work in the United States

Please apply online on www.leoni.com or send your resume to divya.chopra@leoni.com.