Embark on a career-defining opportunity as a Quality Assurance Director. Lead excellence and regulatory compliance in the medical technology sector, overseeing global quality operations, strategy, and product safety standards worldwide.
About the Role
As a seasoned professional, spearhead quality and regulatory affairs, driving strategic vision, technical expertise, and leadership in navigating U.S. and European regulatory frameworks. Develop and direct overall Quality & Regulatory strategy, aligning with business objectives, and lead regulatory submissions and maintain relationships with authorities in major markets.
Key Responsibilities
* Evaluate and ensure compliance with medical device regulations, including U.S. FDA, European MDR, and other applicable standards.
* Implement and continuously improve an ISO-certified Quality Management System, maintaining adherence to critical product standards, including IEC software lifecycle and electrical safety.
* Manage audits, risk assessments, and corrective/preventive actions, collaborating with R&D, Clinical, and Operations teams to embed compliance throughout the product lifecycle.
* Monitor regulatory changes and proactively adapt internal processes, mentoring, developing, and inspiring the QA/RA team to foster a culture of compliance and continuous improvement.
What You'll Bring
* Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
* Extensive experience in senior QA/RA roles within the medical device sector, demonstrated expertise with FDA submissions (510(k), PMA) and European MDR compliance.
* Strong knowledge of IEC, ISO, and relevant international standards, with a track record of successfully leading audits and managing quality systems.
* Excellent communication, leadership, and organizational skills.