Job Description

Director of Quality and Regulatory Affairs

Charlotte, NC

ISC’s team of Manufacturing Recruiters is partnering with a thriving Medical Device company to identify an experienced Director of Quality and Regulatory Affairs (Q&RA) to provide global leadership.

The Director of Q&RA will lead the development and implementation of global quality and regulatory policies, ensuring effective structures, systems, and processes for long-term success. This role provides technical leadership, collaborates across functions, drives continuous improvement, and oversees compliance with FDA, Health Canada, and NHS regulations.

Director of Q&RA Qualifications:

• Bachelor’s Degree required
• 7+ years of Quality and Regulatory Affairs experience in the Medical Device industry
• 5+ years of Leadership experience
• Deep knowledge of quality practices in FDA-regulated and ISO-certified product development, manufacturing, and operations
• Experience across all phases of the product development lifecycle
• Ability to present to all levels and all sizes of organizations and agencies
• Strong global understanding of ISO audits, FDA, and EPA
• Lean manufacturing knowledge
• Ability to travel up to 25%
• Self-starter, assertive, motivating, analytical, organized, positive, personable, and innovative with exceptional communication skills

Director of Q&RA – our client offers:

• Collaborative, innovative, and passionate team who is there to help you succeed and grow
• Well-established, stable, and successful company
• $130-150k base plus 15% bonus; Medical, Dental, Vision, Life, Disability, 401k, PTO, EAP, FSA, and Wellness Program

Director of Q&RA Responsibilities:

• Provide strategic operational insight, ensuring Quality & Regulatory Affairs aligns with company strategy
• Develop and implement quality and regulatory strategies to enhance effectiveness and compliance
• Implement systems to monitor and ensure quality, safety, compliance, and continuous improvement
• Serve as the Official Correspondent and regulatory signatory for FDA, Health Canada, and NHS
• Implement systems to monitor and ensure quality, safety, compliance, and continuous improvement
• Drive quality and regulatory improvements across all stages, from design to delivery
• Lead and develop a strong team through leadership, training, and mentorship
• Identify cost-saving opportunities in quality and regulatory processes
• Collaborate cross-functionally to integrate quality and regulatory activities with company objectives
• Oversee Regulatory Affairs, ensuring compliance and managing legal interactions related to product claims
• Authorize release of new or transitioned products, ensuring all regulatory requirements are met

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