Senior Quality & Regulatory Manager

Required Skills & Experience

Qualifications

• Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related technical field.
• 5–8 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
• Experience with software as a medical device (SaMD), medical device software, and cloud deployment, experience in these areas is strongly preferred.
• Demonstrated experience managing a QMS, supporting audits and regulatory inspections, and maintaining quality and regulatory documentation.
• Experience supporting or leading regulatory submissions, ideally including FDA 510(k) submissions, EU MDR documentation, and international registrations.
• Working knowledge of FDA 21 CFR Part 820 / FDA QMSR, ISO 13485, ISO 14971, CAPA, design controls, and software lifecycle practices such as IEC 62304.
• Knowledge of medical device software lifecycle and validation principles, including IEC 62304, and familiarity with usability engineering under IEC 62366.
• Understanding of post-market surveillance, complaint investigations, adverse event reporting, and supplier quality management.
• Familiarity with software cybersecurity documentation, such as SBOMs, threat modeling, and vulnerability management, is preferred.
• Strong technical writing, analytical, organizational, communication, and problem-solving skills.
• Ability to work independently, manage competing priorities, and collaborate effectively across technical and business teams.

Job Description

Quality Systems and Software Development

• Maintain, and continuously improve the Quality Management System in accordance with applicable FDA requirements, FDA QMSR, ISO 13485, and other relevant medical device standards.
• Manage quality documentation, document control, training records, change control, nonconformance processes, and Corrective and Preventive Action (CAPA) activities.
• Maintain QMS processes suited to software-driven products, cloud infrastructure, continuous integration, DevOps workflows, and Agile development.
• Partner with development team to maintain traceability linking user stories, software requirements, hazard analyses, and verification and validation (V&V) test cases. Regulatory Affairs and Post-Market Compliance
• Support and lead, as appropriate, global regulatory submissions, product registrations, and ongoing regulatory compliance, including FDA 510(k) submissions, EU MDR Technical Files, and international registrations.
• Assess software patches, feature releases, and product changes to determine regulatory impact and appropriate documentation, including internal assessments, letters-to-file, or new submissions where required.
• Monitor changes to applicable regulatory requirements and standards and implement updates to quality and regulatory processes.
• Oversee complaint handling, triage, and technical investigations involving customer complaints, software bugs, and product performance issues; collaborate with Product Support and Engineering to identify root causes.
• Evaluate software anomalies and performance issues against applicable global adverse event reporting requirements, including FDA Medical Device Reporting (MDR) and EU Vigilance, and coordinate timely reporting when required.
• Oversee nonconformance investigations and use post-market feedback to identify trends and drive continuous quality improvement. Risk Management, Cybersecurity, and Product Quality
• Maintain design control, risk management, verification, and validation documentation throughout the product lifecycle.
• Drive risk management activities in accordance with ISO 14971, including assessment of software anomalies, defects, and deployment regressions during iterative development.
• Support software lifecycle and validation activities consistent with IEC 62304.
• Support usability engineering and human factors activities consistent with IEC 62366, including validation of user interface updates for safe use.
• Maintain applicable cybersecurity documentation, including SBOMs, threat modeling, and vulnerability management plans.

Audits, and Release Quality

• Coordinate internal and external audits and support regulatory inspections, including preparation, follow-up, and corrective actions.
• Define and execute release-quality processes for software and hardware products to ensure applicable specifications and controlled records are met.
• Maintain appropriate release documentation and ensure release decisions are supported by required quality, verification, validation, risk, and regulatory records.
• Collaborate cross-functionally with Engineering, Clinical, Product Management, Operations, and other stakeholders to maintain product quality and regulatory compliance.