Director of Quality Assurance & Regulatory Affairs

@ Sunrise Medical (US) LLC

Position Summary

The Director of Quality Assurance & Regulatory Affairs will develop, implement, and maintain a comprehensive QA/RA system for Sunrise Medical in North America. This role ensures that all products meet customer and internal stakeholder expectations, and complies with US and international regulatory requirements.

Principal Job Duties & Responsibilities

Manage, coordinate, and administer quality assurance and regulatory activities across the Nashville site and other affiliated divisions. Oversee submission tasks, training, product development review, CAPA, supplier quality, and post-market surveillance. Serve as the official contact for regulatory bodies including the FDA and Health Canada, and represent the company during audits and inspections.

• Implement and manage quality and regulatory programs.
• Lead a cross-functional team to ensure compliance.
• Drive continuous improvement and corrective actions.
• Oversee product submissions, technical file compilations, and market strategy.
• Manage relationships with global regulatory bodies.

Required Skills, Knowledge, and Experience

Bachelor's degree in Engineering or a related technical field with a minimum of 10 years experience; 5 years in a quality leadership role. Must have hands-on experience in manufacturing environments and familiarity with FDA, Health Canada, and international standards.

Competencies

Key competencies include analytical thinking, collaborative relationship building, decisiveness, and effective communication. Emphasis on continuous improvement, attention to detail, and an ability to work under pressure.

Physical Requirements & Travel

Ability to work extended hours, travel domestically and internationally, and perform the essential functions of the role.

Key skills/competency

• Quality Assurance
• Regulatory Affairs
• Compliance
• Continuous Improvement
• Audit
• CAPA
• FDA
• Leadership
• Risk Management
• Team Management