Senior QARA & Risk Manager - Remote AI-Driven Quality

Topcon Positioning Group; New Jersey; Hybrid; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) match

Tuition reimbursement

Paid holidays

Paid time off

Sick time

Job summary

Topcon Healthcare seeks a Senior Quality Assurance & Regulatory Affairs Specialist / Risk Manager to lead QARA for medical device software and risk management. This dual role blends Regulatory affairs and risk activities with AI-driven automation in a global, cross-functional setting.

You’ll drive ISO 14971 risk management, IEC 62304 lifecycle integration, and regulatory submissions while modernizing workflows to include AI-assisted verification and controls. Remote-friendly in the US time zones.

Qualifications

• 5+ years of experience in medical device Quality Assurance, Regulatory Affairs, risk management, or related field.
• Strong knowledge of medical device regulations and standards (FDA requirements, QMSR/21 CFR 820, ISO 13485, ISO 14971, IEC 62304).
• Experience with SaMD or software-containing medical devices, design controls, DHF/technical docs, V&V, traceability, CAPA, PMS, audits, and regulatory submissions.

Responsibilities

• Support development and ongoing improvement of Quality Management System per applicable requirements (FDA QMSR / 21 CFR Part 820, ISO 13485).
• Support design controls, DHF and technical documentation, risk documentation, traceability, labeling inputs, and release evidence.
• Participate in design reviews and assess impact of changes on quality and regulatory compliance.
• Lead risk management activities and maintain Risk Management Plans in accordance with ISO 14971/2019.
• Facilitate hazard identification, risk analysis, risk evaluation, controls, verification of effectiveness, and residual risk evaluation.

Skills

QA & RA

Risk management

SaMD

Software lifecycle

Regulatory affairs

FDA QMSR/21 CFR 820

ISO 13485

ISO 14971

IEC 62304

AI automation

Education

Bachelor’s or Master’s in biomedical engineering / software engineering / computer science / health tech / life sciences / quality engineering / regulatory affairs

Tools

DHF/technical documentation

Job description

Topcon Healthcare seeks a Senior Quality Assurance & Regulatory Affairs Specialist / Risk Manager to lead QARA for medical device software and risk management. This dual role blends Regulatory affairs and risk activities with AI-driven automation in a global, cross-functional setting.

You’ll drive ISO 14971 risk management, IEC 62304 lifecycle integration, and regulatory submissions while modernizing workflows to include AI-assisted verification and controls. Remote-friendly in the US time zones.