Senior SaMD Quality & Regulatory Leader

Insight Global; Beachwood (OH); On-site; USD 120,000 - 170,000; Full time

Job summary

Insight Global is seeking an experienced Quality Systems and Regulatory Affairs professional to maintain and improve QMS for SaMD and cloud-based products. You will lead regulatory submissions (FDA 510(k), EU MDR) and ensure ongoing compliance with FDA, ISO, and IEC standards across the product lifecycle.

The role emphasizes risk management, software lifecycle practices, cybersecurity documentation, and cross-functional collaboration with Engineering, Product, and Operations.

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, 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.

Responsibilities

• Maintain, and continuously improve the Quality Management System in accordance with FDA requirements, FDA QMSR, ISO 13485, and other medical device standards.
• Manage quality documentation, document control, training records, change control, nonconformance processes, and CAPA activities.
• Maintain QMS processes suited to software-driven products, cloud infrastructure, CI, DevOps, and Agile development.
• Partner with development team to maintain traceability linking user stories, software requirements, hazard analyses, and V&V test cases.
• Support global regulatory submissions, product registrations, and ongoing regulatory compliance including FDA 510(k) submissions and EU MDR documentation.
• Assess software patches and product changes for regulatory impact and documentation needs.
• Oversee complaint handling, investigations, and root cause analysis with cross-functional teams.
• Oversee post-market surveillance, adverse event reporting, and supplier quality management.
• Maintain design control, risk management, verification, and validation documentation throughout the product lifecycle.
• Drive risk management in accordance with ISO 14971 and IEC 62304 compliance.
• Support usability engineering per IEC 62366 and SBOMs/vulnerability management.

Skills

QMS management

Regulatory affairs

SaMD

FDA 510(k)

ISO 13485

IEC 62304

Risk management

Cybersecurity knowledge

Technical writing

Cross-functional collaboration

Education

Bachelor’s degree in Engineering/Regulatory/Life Sciences

Tools

Cloud deployment

CI/CD

DevOps

Hazard analyses

Job description

Insight Global is seeking an experienced Quality Systems and Regulatory Affairs professional to maintain and improve QMS for SaMD and cloud-based products. You will lead regulatory submissions (FDA 510(k), EU MDR) and ensure ongoing compliance with FDA, ISO, and IEC standards across the product lifecycle.

The role emphasizes risk management, software lifecycle practices, cybersecurity documentation, and cross-functional collaboration with Engineering, Product, and Operations.