Director of Quality and Regulatory Affairs

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Director of Quality and Regulatory Affairs

This is a unique opportunity to lead quality and regulatory strategy at a highly respected organization in the medical device space. The role offers a chance to make a measurable impact by ensuring compliance, protecting the business, and driving continuous quality improvement across the organization.

Benefits and Compensation

• Competitive base salary with performance incentives
• Comprehensive health, dental, and vision insurance
• Company-paid life insurance and disability coverage
• Paid time off (vacation, holidays, and sick time)
• 401(k) retirement plan with company contribution
• Professional development and continuing education support
• Collaborative and mission-driven work environment

Requirements & Qualifications

• Bachelor’s degree required; advanced degree preferred (or equivalent work experience)
• Minimum 10 years of experience in a regulated medical device environment
• Proven expertise with FDA 21 CFR Part 820, ISO 13485, and Health Canada quality system requirements
• Demonstrated success managing quality systems that have been FDA audited and ISO certified
• Strong background in regulatory affairs, auditing, and CAPA systems

Must Haves

• Direct and manage all regulatory requirements impacting the organization
• Oversee the Quality Management System (QMS) to ensure compliance with FDA, ISO, and Health Canada standards
• Develop, document, and manage an Internal Audit Program (ISO 19011:2018)
• Lead the Quality Assurance/Quality Control department and ensure processes meet customer specifications
• Manage complaint handling, nonconformance, and corrective/preventive action programs
• Provide regular reports to senior leadership on QMS performance and opportunities for improvement
• Promote awareness of regulatory and customer requirements throughout the company
• Serve as liaison with regulatory agencies and external auditors

Preferred Background & Skills

• Advanced degree in engineering, life sciences, or regulatory affairs
• Professional certifications (e.g., RAC, ASQ CQA, CQE, or similar)
• Experience leading cross-functional teams and training programs
• Strong problem-solving and root-cause analysis skills
• Excellent communication skills and ability to interact with regulatory bodies and senior leadership

At Goodwin Recruiting, we are committed to our core values and providing world class customer service. We are committed to helping our clients navigate and comply with the complex and ever-changing labor laws as well as help ensure that in every hiring decision, internally and with our client partners, that all viable candidates are considered, and the most qualified candidate is offered the role. We evaluate the knowledge, skills, and abilities that meet the requirements of the position and aim to open doors and change lives. We value all people, understanding that uniqueness and diversity foster a stronger team that is innovative and brings varying perspectives to the table. We put our money where our mouth is and are proud of our efforts to identify a broad slate of candidates, with many hiring success stories to share.

JOB ID: 165166

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Samantha McDermott

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