Director of Quality and Regulatory Affairs

RESPONSIBILITIES:

• The QA/RA Director is responsible for the oversight of the QA and RA team leaders, managing the day-to-day activities, projects, ensuring that all Directors, process owners, and supervisors develop and maintain their part of the quality management system.
• Responsible for planning and monitoring of teams’ budget, resources, work allocations.
• Develops employees and evaluates work performance in order to maximize employee's potential and impact on the organization.
• Provides environment for professional development, guides and executes QA, RA activities of the Company.
• Responsible for ensuring the quality of products, processes and services in accordance with applicable regulatory requirements.
• Translates regulations, requirements, and guidelines into company policy/procedures and trains personnel accordingly.
• Evaluates sources of processes to determine root causes and to implement appropriate corrective and preventive actions. Ensures effectiveness of corrective and preventive actions implemented.
• Develop and monitor a complaint management system
• Internal and external audits including supplier approval and evaluation.
• Prepares regulatory strategies/plans and worldwide compliance requirements. Provides on-going support to project teams for regulatory issues and questions.
• Reviews sales and marketing materials for regulatory compliance.
• Maintains regulatory product files to support compliance with regulatory requirements.

REQUIREMENTS:

• Bachelor's Degree in healthcare/life science/Engineering disciplines required.
• At least 5 years of work experience in the medical device industry, in QA and RA positions, including 3 or more years of management, providing work direction and leadership to people.
• Previous experience with ISO 13485, CE MDD/MDR certification process required.
• Previous experience with US and international medical device regulations required.
• In-depth knowledge of the following: ISO 13485, ISO 14971, EU Directives and CFR 21 Part 820.
• Excellent Communications Skills both written and verbal.
• Detail-oriented with the ability to prioritize efficiently and multi-task.
• Ability to adapt to new challenges, learn quickly, and take action while engaging in a fast-moving, growing environment.

Traveling may be required.