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
