This is regarding excellent job opportunity with my client...!!!
Title: QA/RA Manager
Location: Durham, NC On Location Only
Duration: 6 month contract to hire
10+ years of QARA experience in software medical device regulated industry.
Strong working knowledge of Quality Management System requirements and EU MDR’s
Experience and knowledge regulatory authority inspections and audits.
Develop and continuously improve all facets of Quality Management System in accordance with global regulatory requirements, including but not limited to FDA 21 CFR Part 820, EN ISO 13485, MDSAP, EU MDR, etc.
• Develop Quality Plans for significant QMS changes and manage to completion. Notify regulatory agencies of changes, and host onsite or desk-top audits, as required.
• Stay abreast of global regulatory changes. Conduct gap analyses and develop proposals to remain compliant.
• Create robust supplier management program for Tier 1 Critical Suppliers.
• Actively plan for and participate in external global regulatory agency audits/inspections.
• Manage internal audit program. Work with cross-functional teams to address potential compliance issues, define and implement corrective action and preventive actions, and monitor effectiveness post-implementation.
• Lead Post Market Surveillance meetings and determine if issues require field notifications and recalls.
• Schedule and serve as lead in Management Review meetings.
• Participate in the development of global regulatory strategies for artificial intelligence and machine learned software medical devices. Work closely with Product Owners throughout the development lifecycle.
Thanks & Regards,
16192, Coastal Highway, Lewes, Delaware, USA