Manager Quality Assurance & Reg Affairs | AirStrip

Accountabilities

• Develop, implement, and maintain Quality System Documentation (QSDs) to ensure compliance with FDA regulations, 21 CFR Part 820, MDSAP requirements, and other applicable standards governing Software as a Medical Device (SaMD).

• Support external audits and inspections conducted by notified bodies and regulatory authorities, providing expertise and ensuring audit readiness.

• Collaborate with New Product Development (NPD) and Existing Product Enhancement (EPE) teams throughout the product lifecycle, contributing to Design History Files (DHF), Technical Files, Risk Management Files, Clinical Evaluation Reports, and Post-Market Surveillance documentation.

• Participate in nonconforming product and customer complaint processes, ensuring issues are properly identified, documented, evaluated, investigated, and resolved in a timely manner.

• Lead and support Corrective and Preventive Action (CAPA) initiatives to address systemic quality issues, prevent recurrence, and drive continuous improvement.

• Coordinate internal and supplier audits, ensuring they are conducted according to established audit programs, applicable regulations, and international quality standards.

• Monitor and analyze CAPA, complaint, clinical evaluation, and post-market surveillance data, preparing reports and insights for management review meetings.

• Maintain and support international regulatory certifications and market authorizations, including ISO 13485:2016, MDSAP, MDD/MDR, UKCA, and CMDCAS registrations.

• Build and maintain a regulatory and compliance knowledge base to facilitate access to current requirements, monitor regulatory changes, and generate compliance performance insights.

Requirements:

• Bachelor's degree in Healthcare, Information Technology, Quality Management, or a related discipline. Equivalent professional experience may be considered in place of a degree.

• At least 5 years of experience managing Quality Assurance and Regulatory Affairs activities within the medical device industry.

• Minimum 5 years of experience interpreting and applying FDA guidance, regulations, and requirements from international regulatory authorities.

• Proven knowledge of medical device quality and regulatory frameworks, including MDSAP, MDR, UKCA, ISO 13485, and QMSR.

• Strong understanding of risk assessment, risk management methodologies, and regulatory compliance processes.

• Experience managing and continuously improving Quality Management Systems, including CAPA, complaint handling, audits, and post-market surveillance.

• Excellent organizational, planning, coordination, and follow-up skills, with strong attention to detail.

• Outstanding written and verbal communication skills, with the ability to collaborate effectively across multidisciplinary teams.

• Strong analytical thinking and problem-solving abilities, combined with a proactive, results-oriented approach.

• Creative and innovative mindset, with the ability to identify opportunities for process improvement and operational excellence.

• Demonstrated ability to coach, mentor, and support team members while fostering a culture of accountability and continuous improvement.

Benefits:

• Annual base salary: $100,700–$126,000, depending on qualifications, professional experience, and geographic location.

• 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.

• Life and disability insurance.

• Employee Assistance Program (EAP).

• Financial planning assistance.

• Physical and mental wellness programs and discounts.

• Access to an online learning platform and professional development opportunities.

• Discounts on selected mobile phone plans.

• Additional employee wellness, growth, and development benefits.

• Travel may be required as part of the position.