Sr. Director – Quality Assurance and Regulatory Affairs – Qara – Endoscopy

Sr. Director – Quality Assurance and Regulatory Affairs – Qara – Endoscopy

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related field
• 15+ years of relevant progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry or an advanced degree with a minimum of 13 years of relevant progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry
• 10+ years of people leadership, including global team management
• Demonstrated experience with FDA, EU MDR, and global regulatory submissions and inspections.

Responsibilities

• Lead a global team responsible for the Regulatory and Quality needs of a diverse and technologically advanced portfolio.
• Build organizational capability through mentoring, succession planning, and professional development while fostering a culture of continuous improvement and regulatory excellence.
• Establish clear performance metrics, develop team capabilities, and implement strategies to attract, retain, and grow top talent in quality and regulatory disciplines.
• Build strong regulator relationships.
• Develop and execute global regulatory strategies to support product approvals, new market entries, and portfolio expansion.
• Ensure timely and high-quality regulatory submissions and interactions with global health authorities.
• Deeply understands and can articulate how regulatory creates value.
• Translate scientific information to regulatory strategy.
• Serve as the primary regulatory advisor to cross-functional teams and executive leadership.
• Experience across a range of geographies and device risk classifications.
• Experience leading through challenging situations (e.g., Warning Letter remediation).
• Develop and implement OU Quality strategy and plans that drive significant improvements, and are aligned with OU, Region, GOSC Quality and Enterprise strategic priorities.
• Responsible for the global quality system (QMS) for Endoscopy, ensuring compliance with ISO, FDA, and other international regulatory standards.
• Lead quality initiatives to support product lifecycle management, manufacturing scale-up, and continuous improvement ensuring the highest reliability in new product introduction programs according to DRM principles.
• Establish quality metrics and drive a culture of accountability, inspection readiness, and operational excellence.
• Direct the internal and external audit program within Endoscopy, ensuring inspection readiness, managing notified body relationships, and overseeing successful regulatory agency inspections.
• Partner with R&D, Clinical, Operations, and Marketing to influence product development and commercialization strategies from a regulatory and quality perspective.
• Collaborate with regional QA/RA teams to ensure alignment and consistency in quality and regulatory practices worldwide.
• Collaborate with enterprise and regional Quality and Regulatory teams as well as GOSC Quality.

Preferred Qualifications

• Advanced degree (MS, PhD, RAC certification, or MBA).
• Experience working in a global matrixed MedTech organization.
• Knowledge of gastrointestinal diagnostics or endoscopy.
• Strong communication, leadership, and cross-functional collaboration skills.
• Understanding of Medical AI fundamentals – how AI is applied in areas like diagnostics, clinical decision support, imaging, etc.
• Familiarity with evolving regulatory landscapes, especially FDA requirements related to AI.
• Awareness of the AI lifecycle – including risks like bias, drift, and overfitting.
• Ability to navigate uncertainty – building regulatory strategies to manage AI-related risks and ensure compliance.