Senior Quality Assurance Analyst - Regulatory Affairs

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
• Required
• 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
• Key Competencies
• 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
• Preferred
• 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
• This job description is not intended to be an exhaustive list of duties, responsibilities, or qualifications and may be modified at any time to meet business needs.
• All your information will be kept confidential according to EEO guidelines.
• Applicants may be required to complete an online technical and/or personality assessment as part of your application.
• #LI-REMOTE

Benefits

Additional Information

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.

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