Manager of Quality Assurance & Regulatory Affairs | AirStrip

AirStrip is seeking a Manager of Quality Assurance & Regulatory Affairs. In this role, you'll play a critical role in ensuring compliance with global regulatory standards for all AirStrip technologies. You'll lead the development and maintenance of Quality System Documents, support audits and regulatory inspections, and contribute to product development and post-market activities. Your expertise will drive continuous improvement through CAPA, internal audits, and management reviews while maintaining key international certifications and regulatory authorizations.

This position offers the flexibility to work remotely within the United States, or in a hybrid capacity from our office in San Antonio, TX.

Responsibilities include, but are not limited to:

• Develop, implement, and maintain Quality System Documents (QSD) in order to assure compliance of the Company’s Quality System with MDSAP, 21 CFR Part 820 and any other FDA guidance and regulations related to SaMDs
• Participate during audits conducted by Notified and Regulatory bodies by providing professional support and expertise for Quality Assurance and Regulatory Affairs topics
• Participate as team member of New Product Development (NPD) or Existing Product Enhancement (EPE) Teams during all phases of the development of the Design History Files (DHFs)Technical Files (TFs) as well as Risk Management, Clinical Evaluation or Post-Market Surveillance Files.
• Participate in the Nonconforming Product and Complaint Processes in order to identify, document, evaluate, segregate and disposition in a timely manner the Nonconforming Product and/or Customer Complaints.
• Solve the systemic Product Non-Conformances (NCs) through the Corrective Actions Preventative Actions (CAPA) Process in order to eliminate or prevent the occurrence of these NCs
• Participate in and ensure timeliness of Internal Audits according to the Company’s Audit Programs and current standards and regulation requirements
• Organize and coordinate the CAPA, Complaints, Clinical Evaluation and Post-Market Surveillance data collection, monitoring, analysis and report for the Management Review meetings
• Maintain international authorizations including but not limited to ISO 13485:2016, MDSAP, MDD/ MDR Certifications, UKCA, and CMDCAS registrations, as well as the regulations that apply to any area the Company determines are in its best interest.
• Establishing compliance “knowledge base” that can be mined to extract compliance statistics and current regulations

Education & Experience Requirements:

• Bachelor's degree from an accredited university in Healthcare, IT, Quality, or related field (preferred, although commensurate experience will be considered in lieu of degree)
• Minimum 5 years of experience managing the oversight of QA/RA in medical device industry
• Minimum 5 years of experience understanding guidance’s from FDA and international regulatory agencies.

Knowledge, Skills, and Abilities:

• Strong organizational, planning, and follow-up skills
• Strong interpersonal communication (written and verbal)
• Effective problem-solving skills; results-oriented
• Outstanding attention to details
• Creative and innovative thinker
• Continuous improvement for QMS
• Proven compliance with the current and applicable standards and regulations such as MDSAP, MDR, UKCA, ISO 13485, QMSR, etc.
• Strong understanding of risk management

The anticipated salary range for applicable US-based applicants to this position is below. The specific rate will depend on the successful candidate’s qualifications, prior experience as well as geographic location.