Senior QARA & Risk Manager – AI-Driven MedTech

Topcon Healthcare Inc.; 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) with employer match

Tuition reimbursement

Paid holidays

Job summary

Topcon Healthcare Inc. is seeking an experienced Senior Quality Assurance & Regulatory Affairs (QARA) Specialist / Risk Manager to support medical device software and digital health products.

The role is a dual responsibility—approximately 50% QARA and 50% product risk management—working with global teams to ensure compliance with FDA QMSR/21 CFR 820, ISO 13485, ISO 14971, and IEC 62304. Flexible AI-enabled workflows are emphasized.

Qualifications

• 5+ years of relevant experience in medical device QA, regulatory affairs, risk management, or related field.
• Strong knowledge of medical device regulations and standards, especially FDA requirements, QMSR / 21 CFR 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.
• Practical experience with medical-device risk management, including risk analysis, controls, verification evidence, and risk reports.
• Strong analytical, documentation, and technical-writing skills; fluent English; ability to work with global teams.
• Able to apply AI/automation concepts within regulated environments with appropriate oversight.

Responsibilities

• Support development and improvement of the Quality Management System per FDA QMSR 21 CFR 820 and ISO 13485.
• Maintain design controls, DHF, and technical documentation including requirements, specs, V&V, risk docs, traceability, labeling, and release evidence.
• Participate in design reviews and assess quality and regulatory impact of changes.
• Support global regulatory submissions and post-market activities.
• Contribute to CAPA, PMS, audits, document control, and change control; integrate risk management with software lifecycle.
• Act as Risk Manager for assigned medical device software products; develop Risk Management Plans per ISO 14971.

Skills

QARA regulatory knowledge

Quality Assurance

Risk management

FDA QMSR / 21 CFR Part 820

ISO 13485

IEC 62304

SaMD experience

Regulatory submissions

Regulatory documentation

English proficiency

Education

Bachelor's or Master's in biomedical engineering / regulatory affairs / related field

Tools

ISO 14971 risk management

Job description

Topcon Healthcare Inc. is seeking an experienced Senior Quality Assurance & Regulatory Affairs (QARA) Specialist / Risk Manager to support medical device software and digital health products.

The role is a dual responsibility—approximately 50% QARA and 50% product risk management—working with global teams to ensure compliance with FDA QMSR/21 CFR 820, ISO 13485, ISO 14971, and IEC 62304. Flexible AI-enabled workflows are emphasized.