Senior Quality Assurance Analyst - Regulatory Affairs

Job 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

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.

Additional Information

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

Intelerad is committed to the principles of equal employment. We are committed to complying with all federal, state and local laws providing equal employment opportunities and all other employment laws and regulations. Applicants, employees and former employees are protected from employment discrimination based on race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), national origin, age , disability and genetic information (including family medical history). Intelerad is dedicated to the fulfillment of this policy regarding all aspects of employment, including but not limited to recruiting, hiring, placement, transfer, training, promotion, rates of pay, and other compensation, termination, and all other terms, conditions, and privileges of employment. 

Intelerad is committed to ensuring equal employment opportunity for qualified individuals with disabilities. Intelerad uses the Americans with Disabilities Act (“ADA”)as a standard for global recruiting and hiring purposes. This prohibits discrimination against qualified individuals with disabilities. The ADA defines “disability” as a physical or mental impairment that substantially limits one or more of the major life activities of an individual, a record of such impairment, or being regarded as having such an impairment