Manager, Quality Assurance & Regulatory Affairs | AirStrip | Remote

NantHealth•San Antonio, TX

19h•Remote

About The Position

AirStrip is seeking an experienced Manager of Quality Assurance and Regulatory Affairs to lead continuous improvement initiatives across the company’s Quality Management System and ensure compliance with global regulatory standards, including MDSAP, MDR, UKCA, ISO 13485, and QMSR. The role applies risk assessment to support business objectives and calls for strong organizational, communication, and problem-solving skills, attention to detail, and a results-oriented mindset. The successful candidate will collaborate with team members, mentor others, and drive quality, compliance, and operational excellence. The position requires up to 30% travel to company offices and client sites for corporate and client meetings. It directly supervises the QA/RA Associate Project Manager.

Requirements

Bachelor’s degree in Healthcare, IT, Quality, or a related field; commensurate experience may be considered in lieu of a degree.
At least 5 years of experience managing QA/RA in a medical device company.
At least 5 years of experience understanding guidance from the FDA and international regulatory agencies.
Strong organizational, planning, and follow-up skills.
Strong written and verbal interpersonal communication skills.
Effective problem-solving skills and a results-oriented approach.
Outstanding attention to detail.
Creative and innovative thinking.
Ability to coach and mentor direct reports.
Experience with continuous improvement for a QMS.
Proven compliance with current and applicable standards and regulations such as MDSAP, MDR, UKCA, ISO 13485, and QMSR.
Strong understanding of risk assessment.

Responsibilities

Develop, implement, and maintain QSDs to ensure the Company’s Quality System complies with MDSAP, 21 CFR Part 820, and other FDA guidance and regulations related to SaMDs.
Provide professional support and expertise on Quality Assurance and Regulatory Affairs topics during audits conducted by Notified and Regulatory bodies.
Participate in New Product Development (NPD) or Existing Product Enhancement (EPE) teams throughout development of Design History Files (DHF), Technical Files (TF), Risk Management files, Clinical Evaluation files, and Post-Market Surveillance files.
Participate in nonconforming product and complaint processes to identify, document, evaluate, segregate, and disposition nonconforming products and customer complaints in a timely manner.
Address systemic product non-conformances through the Corrective Actions Preventative Actions (CAPA) process to eliminate or prevent their occurrence.
Participate in and ensure timely completion of internal and supplier audits according to the Company’s audit programs and applicable standards and regulations.
Organize and coordinate CAPA, complaints, clinical evaluation, and post-market surveillance data collection, monitoring, analysis, and reporting for Management Review meetings.
Maintain international authorizations, including ISO 13485:2016, MDSAP, MDD/MDR certifications, UKCA, and CMDCAS registrations, and maintain applicable regulations in areas the Company determines are in its best interest.
Establish a compliance knowledge base for extracting compliance statistics and current regulations.
Build expertise over time on topics such as cloud computing.
Directly supervise the QA/RA Associate Project Manager.
Implement ongoing, proactive compliance decisions, including European Conformity (CE) requirements.
Upgrade processes to meet upcoming MDR requirements.
Ensure proper handling and ongoing regulatory and quality maintenance of AirStrip solutions in designated markets.
Participate in AirStrip’s responses to compliance questionnaires for Enterprise Users.
Perform hands-on work to ensure corporate SOPs comply with FDA, CE, MDSAP, ISO, DIACAP, and general quality principles.