Manager, Quality Assurance, Regulatory Affairs

This is a fully remote position, open to applicants in Texas.

📋 Description

• Lead ongoing improvement efforts within AirStrip’s Quality Management System.

• Ensure adherence to global regulatory standards, including MDSAP, MDR, UKCA, ISO 13485, and QMSR.

• Develop, execute, and uphold Quality System Documents (QSDs) to align with the Company’s Quality System, 21 CFR Part 820, and FDA guidance regarding Software as a Medical Device (SaMD).

• Engage in audits performed by Notified and Regulatory bodies.

• Assist New Product Development and Existing Product Enhancement teams throughout the creation of Design History Files (DHF), Technical Files, Risk Management, Clinical Evaluation, and Post-Market Surveillance Files.

• Contribute to Nonconforming Product and Complaint Processes.

• Address systemic product non-conformances through the Corrective and Preventive Action (CAPA) Process.

• Ensure timely execution of Internal and Supplier Audits.

• Organize and coordinate CAPA, Complaints, Clinical Evaluation, and Post-Market Surveillance data for Management Review meetings.

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

• Establish a compliance knowledge base to track compliance statistics and current regulations.

• Develop expertise in areas such as cloud computing.

• Directly supervise the QA/RA Associate Project Manager.

• Implement proactive compliance strategies, including European Conformity (CE) requirements.

• Enhance processes to align with MDR requirements.

• Maintain regulatory and quality compliance for AirStrip solutions in designated markets.

• Engage in responses to Enterprise User compliance questionnaires.

• Ensure corporate Standard Operating Procedures (SOPs) meet FDA, CE, MDSAP, ISO, DIACAP, and general quality principles.

⛳️ Requirements

• Bachelor’s degree in Healthcare, IT, Quality, or a related field; relevant experience may be accepted in lieu of a degree.

• At least 5 years of experience managing Quality Assurance / Regulatory Affairs in a medical device organization.

• Minimum of 5 years of experience comprehending guidance from the FDA and international regulatory bodies.

• Strong organizational, planning, and follow-up capabilities.

• Excellent interpersonal communication skills (both written and verbal).

• Effective problem-solving abilities; focused on results.

• Exceptional attention to detail.

• Innovative and creative thinker.

• Experience in coaching and mentoring direct reports.

• Commitment to continuous improvement of the Quality Management System (QMS).

• Proven track record of compliance with standards and regulations such as MDSAP, MDR, UKCA, ISO 13485, and QMSR.

• Strong knowledge of risk assessment methodologies.

🏝️ Benefits

• Bonus potential.

• Remote work arrangement.

• Up to 30% travel to company office locations and client sites as required.