Senior QARA & Risk Manager - MedTech AI

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k) with employer match

Tuition reimbursement

Paid time off / Holidays

Job summary

Topcon Healthcare seeks an experienced Senior Quality Assurance & Regulatory Affairs (QARA) Specialist / Risk Manager to support medical device software and digital health products. The role is 50% QARA and 50% product risk management, partnering with global teams to ensure compliance throughout the lifecycle.

The candidate will drive modernization of QARA, explore AI-enabled workflows with appropriate verification and oversight, and work in the United States, Eastern Time Zone, with

Qualifications

• 5+ years of regulatory/QA experience in medical devices including SaMD.
• Knowledge of FDA QMSR / 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304.
• Experience with risk management, including risk analysis and CAPA.
• Experience with design controls, DHF/technical documentation, V&V, traceability, and regulatory submissions.
• Fluent English, strong technical-writing and documentation skills.

Responsibilities

• Support the development and continuous improvement of the Quality Management System per FDA/ISO requirements.
• Manage design controls and maintain DHF and technical documentation (requirements, specs, V&V evidence, risk docs, traceability).
• Lead CAPA, PMS, audits, supplier controls, document and change control activities.
• Oversee product risk management lifecycle and align with software lifecycle (IEC 62304, cybersecurity, usability, CAPA).
• Collaborate with global cross-functional teams (Engineering, Clinical, Cybersecurity, Usability, QARA).

Skills

QARA experience

Regulatory affairs

Risk management

Medical device software

Software lifecycle

Education

Biomedical/Software Engineering degree

Regulatory affairs degree (preferred)

Job description

Topcon Healthcare seeks an experienced Senior Quality Assurance & Regulatory Affairs (QARA) Specialist / Risk Manager to support medical device software and digital health products. The role is 50% QARA and 50% product risk management, partnering with global teams to ensure compliance throughout the lifecycle.

The candidate will drive modernization of QARA, explore AI-enabled workflows with appropriate verification and oversight, and work in the United States, Eastern Time Zone, with