Role Description The Senior Quality Assurance Analyst (Regulatory Affairs) is responsible for driving quality and compliance excellence across Intelerad’s Software as a Medical Device (SaMD) portfolio. This role combines deep knowledge of medical device quality systems with hands-on execution of core QA/RA processes, including CAPA, audit readiness, supplier oversight, and regulatory support. As a senior individual contributor within the Regulatory Affairs & Quality organization, this role partners cross-functionally to ensure quality and regulatory requirements are embedded throughout the product lifecycle and that Intelerad maintains a state of continuous compliance. Key Responsibilities - Quality System Execution & Continuous Improvement - Lead and manage Corrective and Preventive Actions (CAPAs), including investigations, root cause analysis, effectiveness checks, and documentation. - Drive improvements to the Quality Management System (QMS) in alignment with ISO 13485, FDA 21 CFR Part 820, and applicable global regulations. - Author, review, and maintain quality system documentation, including SOPs, work instructions, and forms. - Track, trend, and analyze quality metrics to identify systemic issues and improvement opportunities. - Collaborate with development teams in an Agile environment to integrate quality practices throughout the software development lifecycle. - Participate in continuous learning opportunities including training and conferences to stay current with QA methodologies, emerging technologies, and industry best practices. - Audit & Inspection Readiness - Lead and support internal audits to ensure ongoing compliance with regulatory and internal requirements. - Support external audits and inspections (e.g., FDA, Notified Bodies, Health Canada). - Coordinate timely responses to audit findings and ensure effective remediation and closure. - Supplier & Vendor Quality Management - Lead supplier qualification, evaluation, and monitoring activities. - Ensure supplier compliance with quality agreements and regulatory expectations. - Support supplier audits and ongoing performance assessments. - Regulatory Support - Support preparation and maintenance of regulatory submissions and registrations for global markets. - Participate in regulatory impact assessments, change control, and product lifecycle activities. - Collaborate with Regulatory Affairs leadership to support global compliance strategies. - Cross-Functional Collaboration - Partner with R&D, Product, Clinical, and Operations teams to integrate quality and regulatory requirements into development and operational processes. - Provide guidance on risk management (ISO 14971) and design control expectations. - Support complaint handling, post-market surveillance, and vigilance activities. Qualifications - Bachelor’s degree in a scientific, engineering, or healthcare-related field, or equivalent industry experience. - 4+ years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry. - Demonstrated experience working within a certified Quality Management System (ISO 13485). - Strong working knowledge of: - FDA 21 CFR Part 820 / QSR (and QMSR readiness). - ISO 13485. - ISO 14971 risk management principles. - Proven experience managing CAPA, audits, and supplier quality processes. Requirements - Strong analytical and problem-solving skills. - Ability to lead quality initiatives and influence cross-functional stakeholders. - Excellent written and verbal communication skills. - Strong organizational skills with the ability to manage multiple priorities. - Ability to work independently in a regulated, fast-paced environment. Benefits - Experience with electronic QMS platforms (e.g., Greenlight Guru or similar). - Prior experience supporting regulatory inspections. - Familiarity with global regulatory frameworks (EU MDR, UKCA, Health Canada, TGA, etc.). - Quality certifications (e.g., ASQ CQE, CQA). - Experience with Software as a Medical Device (SaMD) or healthcare software a major bonus.