In an ISO 13485 and FDA QSR small company environment, the QA/RA Manager is responsible for all Quality and Regulatory operations; management and oversight including maintenance of the quality system; review of all design, operations, and manufacturing documentation, maintenance of compliance reporting; registration with domestic and international regulatory authorities; and acting as the corporate Management Representative for all quality and regulatory audits. The QA/RA manager also conducts all quality and compliance training, supervises two additional personnel, and interfaces with key management personnel in other related operations.
ESSENTIAL JOB FUNCTIONS INCLUDED BUT NOT LIMIT TO:
Maintain and improves the Quality System, host external auditors, and perform and manage Quality and Regulatory department functions.
Responsible for all aspects of the quality and regulatory system, including the quarterly quality and regulatory management review meeting and reporting.
Works closely with product and process development program changes.
Manages the relationships with all government regulatory organizations and notified bodies, and responds to all regulatory requests leading the company to obtain all required market clearances, approvals, and certifications.
KNOWLEDGE AND SKILL REQUIREMENTS:
- At least a Bachelor’s degree in quality, science, or science-related fields
- Five years experience in quality control and regulatory affairs in the medical devices industry
- Experience using Microsoft Office applications, LMS Systems