Senior QARA & Product Risk Manager (SaMD, AI-Driven)

Topcon Positioning Systems; Oklahoma City (OK); Hybrid; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

Disability Insurance

401(k) with employer match

Tuition reimbursement

Paid time off

Paid holidays

Paid sick time

Job summary

Topcon Healthcare is seeking an experienced Senior Quality Assurance & Regulatory Affairs (QARA) Specialist / Risk Manager to support medical device software and digital health products. This dual role mixes QARA with product risk management to ensure regulatory compliance and product safety across the lifecycle.

You will collaborate with global teams to modernize processes using AI and automation while maintaining rigorous verification, human oversight, and appropriate controls.

Qualifications

• 5+ years in medical device QA, Regulatory Affairs, risk management, or related regulated field.
• Strong knowledge of FDA requirements, QMSR/21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304.
• Experience with SaMD or software-containing medical devices, design controls, DHF/technical documentation, V&V, traceability, CAPA, PMS, audits, and regulatory submissions.
• Experience with risk management, including risk analysis, controls, verification evidence, and Risk Management Reports.
• Professional written and spoken English; ability to work independently with global teams.

Responsibilities

• Support development and continuous improvement of Quality Management System per FDA QMSR/21 CFR Part 820 and ISO 13485.
• Support design controls, DHF and technical documentation, and release evidence.
• Contribute to CAPA, PMS, audits, supplier control, document and change control activities.
• Serve as Risk Manager for assigned medical device software products; develop and maintain Risk Management Plans and Files.
• Facilitate hazard identification, risk analysis/evaluation, and risk controls; ensure integration with software lifecycle and IEC 62304.

Skills

Analytical skills

Documentation

Technical writing

English fluency

Education

Bachelor's or Master's in biomedical engineering or software/health tech

Job description

Topcon Healthcare is seeking an experienced Senior Quality Assurance & Regulatory Affairs (QARA) Specialist / Risk Manager to support medical device software and digital health products. This dual role mixes QARA with product risk management to ensure regulatory compliance and product safety across the lifecycle.

You will collaborate with global teams to modernize processes using AI and automation while maintaining rigorous verification, human oversight, and appropriate controls.