Vice President, Quality Assurance - Regulatory Affairs

• Own and evolve AirStrip’s global regulatory strategy aligned to business goals and product roadmap


• Build and maintain strong relationships with regulatory agencies and industry stakeholders


• Represent AirStrip externally through regulatory engagement, industry participation, and strategic partnerships


• Monitor regulatory trends and translate them into proactive, actionable plans


• Provide strategic direction for global submissions, approvals, and market expansion


• Lead the continued development and continuous improvement of AirStrip’s Quality Management System (QMS)


• Ensure quality processes are scalable, efficient, and aligned with organizational growth


• Maintain consistent readiness for regulatory inspections and audits (e.g., FDA, ISO, MDSAP)


• Provide executive oversight of risk management, quality performance, and compliance programs


• Lead Management Review activities and ensure appropriate escalation and resolution of quality and compliance risks


• Lead, coach, and develop a high-performing QA/RA organization


• Set clear expectations, accountability, and development pathways for team members


• Partner closely with Engineering, Product, Clinical, Security/Privacy, and Legal teams to embed quality and regulatory requirements into development and operations

Requirements

• Bachelor’s degree in a scientific, engineering, clinical, or related discipline (advanced degree preferred)


• 10+ years of progressive leadership experience in Quality Assurance and Regulatory Affairs within medical devices and/or SaMD


• Demonstrated experience working directly with FDA and global regulatory agencies


• Proven track record leading successful regulatory inspections and audits


• Deep working knowledge of quality management systems and regulatory compliance frameworks


• Experience developing regulatory strategy and guiding global submissions and approvals

Core Competencies

Demonstrates expertise in developing and executing global regulatory strategies, ensuring compliance with FDA and international standards while leading high-performing Quality Assurance and Regulatory Affairs teams. Proven ability to build relationships with regulatory agencies and stakeholders, driving quality management and risk management initiatives.

Highest-signal resume keywords

• Regulatory Strategy Development


• Quality Management Systems (QMS)


• FDA Regulatory Experience


• Leadership in Quality Assurance and Regulatory Affairs


• Global Submissions and Approvals

ATS Optimization Keywords

Hard Skills

• Regulatory Compliance


• Quality Assurance


• Risk Management


• Regulatory Inspections


• Audit Management


• Strategic Planning


• Market Expansion


• Continuous Improvement


• Proactive Action Plans


• Team Development

Soft Skills

• Relationship Building


• Coaching


• Accountability


• Collaboration


• Communication

Industry Keywords

• Medical Devices


• SaMD


• FDA


• ISO


• MDSAP


• Regulatory Agencies


• Quality Processes


• Compliance Programs
  
• Stakeholder Engagement


• Industry Participation