Senior QARA & Risk Manager — Remote

Topcon Healthcare; New York (NY); Hybrid; USD 100,000 - 120,000; Full time

Benefits offered by this job

401(k) with employer match

Tuition reimbursement

Paid holidays

Paid time off

Paid sick time

Job summary

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

You will lead risk management activities per ISO 14971, participate in design reviews, support regulatory submissions, and explore AI-enabled

Qualifications

• 5+ years of relevant experience in medical device QA, regulatory affairs, risk management, or related fields.
• Strong knowledge of FDA requirements, QMSR / 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304.
• Experience with SaMD or software-containing medical devices, design controls, DHF/V&V, traceability, CAPA, PMS, audits, and regulatory submissions.
• Practical experience with medical-device risk management, including risk analysis, risk controls, verification evidence, and RM reports.
• Professional fluency in written and spoken English; ability to work with global cross-functional teams.

Responsibilities

• Support the development and improvement of the Quality Management System per FDA QMSR/820 and ISO 13485.
• Maintain design controls and DHF/technical documentation including requirements, specifications, V&V, risk docs, traceability.
• Participate in design reviews and assess regulatory impact of changes.
• Support global regulatory submissions and post-market regulatory activities.
• Contribute to CAPA, PMS, validation, supplier control, audit readiness, document and change control.
• Serve as Risk Manager for assigned medical device software products.
• Establish and maintain Risk Management Plans and Files per ISO 14971.
• Facilitate hazard identification, risk analysis/evaluation and controls; verify effectiveness.
• Integrate risk management with software lifecycle including IEC 62304, cybersecurity, usability, CAPA, PMS.
• Explore AI/automation to modernize QARA processes with proper verification and oversight.

Skills

QA/RA experience

Risk management

Software in medical devices

Regulatory submissions

English communication

Education

Bachelor's or master's in biomedical/related field

ISO 14971 training

Job description

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

You will lead risk management activities per ISO 14971, participate in design reviews, support regulatory submissions, and explore AI-enabled