Manager, Quality Assurance – Regulatory Affairs

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

📋 Description

• Lead ongoing enhancement initiatives within AirStrip’s Quality Management System.

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

• Develop, implement, and uphold Quality System Documents to guarantee compliance with MDSAP, 21 CFR Part 820, FDA guidance, and SaMD regulations.

• Engage in audits conducted by notified and regulatory authorities.

• Provide support to New Product Development and Existing Product Enhancement teams throughout Design History File, Technical File, risk management, clinical evaluation, and post-market surveillance activities.

• Involve in processes related to nonconforming products and customer complaints.

• Address systemic product nonconformities through the CAPA process.

• Participate in and ensure the punctual 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.

• Create a compliance knowledge repository for extracting compliance metrics and monitoring current regulations.

• Develop expertise in areas such as cloud computing.

• Directly oversee the QA/RA Associate Project Manager.

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

• Update processes to align with MDR requirements.

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

• Assist in responses to Enterprise User compliance questionnaires.

• Ensure that corporate SOPs are compliant with FDA, CE, MDSAP, ISO, DIACAP, and general quality principles.

⛳️ Requirements

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

• At least 5 years of experience managing QA/RA in a medical device company.

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

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

• Excellent interpersonal communication, both written and verbal.

• Effective problem-solving abilities; results-driven.

• Exceptional attention to detail.

• Creative and innovative mindset.

• Capable of coaching and mentoring direct reports.

• Committed to continuous improvement of the QMS.

• Demonstrated compliance with MDSAP, MDR, UKCA, ISO 13485, QMSR, and other relevant standards and regulations.

• Strong grasp of risk assessment methodologies.

🏝️ Benefits

• Up to 30% travel to company office locations and client sites as necessary for corporate and client meetings.