Manager Quality Assurance & Reg Affairs | AirStrip

📋 Description

• Develop, implement, and maintain Quality System Documentation (QSDs) to ensure compliance with FDA
• Support external audits and inspections conducted by notified bodies and regulatory authorities
• Collaborate with New Product Development (NPD) and Existing Product Enhancement (EPE) teams
• Participate in nonconforming product and customer complaint processes, ensuring issues are properly
• Lead and support Corrective and Preventive Action (CAPA) initiatives to address systemic quality
• Coordinate internal and supplier audits, ensuring they are conducted according to established audit

🎯 Requirements

• Bachelor's degree in Healthcare, Information Technology, Quality Management, or a related
• At least 5 years of experience managing Quality Assurance and Regulatory Affairs activities within
• Minimum 5 years of experience interpreting and applying FDA guidance, regulations, and requirements
• Proven knowledge of medical device quality and regulatory frameworks, including MDSAP, MDR, UKCA
• Strong understanding of risk assessment, risk management methodologies, and regulatory compliance
• Experience managing and continuously improving Quality Management Systems, including CAPA

🎁 Benefits

• Annual base salary: $100,700–$126,000, depending on qualifications, professional experience, and
• Comprehensive medical, dental, and vision insurance coverage.
• Paid Time Off for hourly employees and Flex Time Off for salaried employees.
• 401(k) retirement savings plan with a 3% company match.
• Paid holidays.
• Paid parental leave, including a flexible return-to-work program.