Senior Director, Quality and Regulatory Affairs

Position Summary:The Senior Director of Quality and Regulatory Affairs for the Instruments and Devices Business will lead QA and RA functions across San Diego, Corvallis, Singapore, and Malaysia. This role ensures regulatory compliance, drives quality improvements, and supports product and process excellence. The individual will partner with cross-functional teams to deliver measurable business outcomes, advocate for system and process investments, and foster a culture of accountability. Reporting to the Managing Director, the leader will build a high-performing team and serve as a key voice for quality and regulatory priorities.Key Responsibilities:Strategic Quality Assurance:Develop QA strategies aligned with business goals, focusing on product quality, compliance, tangible results and customer satisfaction.Actively collaborate with R&D, Operations, Supply Chain, and Program Management to reduce defects and enhance product reliability.Oversee QMS effectiveness, ensuring compliance with ISO9001, ISO 13485, FDA 21 CFR Part 820, MDR, IVDR, and MDSAP.Serve as a visible on-site leader, fostering a quality-first culture.Drive continuous improvement through root cause analysis and risk management methodologies.Leverage digital tools and data analytics to monitor quality metrics, identify trends, and drive proactive improvements across sites.Apply risk management thinking and decision making to designing procedures; effort/cost expended vs severity/probability.Proactive Regulatory Affairs:Create and execute RA strategies to achieve regulatory approvals and maintain global compliance. Monitor and implement updates to regulations and standards, proactively addressing business impact.Serve as the primary contact with regulatory authorities and certification bodies, building strong relationships.Stay abreast of emerging regulations, including software as a medical device (SaMD) and AI-driven medical technologies.Leadership and Advocacy:Build and mentor a high-performing team, ensuring alignment with business objectives.• Advocate for investments in systems, technologies, and processes to enhance quality capabilities.Collaborate and partner with senior leadership to integrate quality and regulatory priorities into business strategies.Prepare and present actionable performance updates to executive management.Lead change-management initiatives to strengthen quality culture, align cross-functional teams, and foster continuous improvement.Operational Excellence:Oversee and improve the Quality Management System (QMS).Lead audits and inspections, ensuring timely resolutions and adherence to findings.Strengthen supplier quality programs and partnerships to ensure consistency across the supply chain.Benchmark quality and regulatory practices against industry standards to ensure best-in- class performance and continuous improvement.Build and maintain strong relationships with clients, ensuring alignment on quality expectations and regulatory requirements.Education and Experience Requirements:Bachelor's degree in Engineering, Life Sciences, or a related field (Master's preferred).Minimum of 12 years in quality and regulatory leadership roles within medical device orlife sciences industries.Proven expertise in ISO 13485, FDA regulations, MDR/IVDR, and global frameworks.Experience implementing QMS and driving quality programs in multi-site, global operations.ASQ (American Society for Quality) certifications (CQE or CMQ/OE).Demonstrated ability to lead cross-functional teams to achieve measurable business improvements.Skills and Competencies:Results-oriented leadership with a strategic mindset and hands-on approach.Strong collaboration and advocacy skills to drive cross-functional alignment.Visible leadership style with a commitment to employee engagement and professionalgrowth.Proficiency in Lean Six Sigma or similar methodologies is a plus.Travel Requirements:Up to 20% travel, including domestic and international locations

Created: 2025-02-22