Senior QARA & Risk Manager – AI-Driven SaMD Quality

Topcon Healthcare; Massachusetts; 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 match

Tuition reimbursement

Paid time off

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 blends QA/regulatory work with product risk management, collaborating with global teams to meet FDA, ISO, and IEC requirements across the lifecycle.

You will drive modernization of QARA processes, explore AI- and automation-enabled workflows, and ensure proper verification and human oversight

Qualifications

• 5+ years in medical device QA, regulatory affairs, risk management, medical device software, or related regulated field.
• Strong knowledge of FDA requirements, ISO 13485, ISO 14971, IEC 62304.
• Experience with SaMD, DHF/technical documentation, V&V, traceability, CAPA, PMS, audits, and regulatory submissions.
• AI/digital quality systems experience is an advantage.

Responsibilities

• Support the development and continuous improvement of the Quality Management System per FDA QMSR 21 CFR 820 and ISO 13485.
• Support design controls and maintain DHF and technical documentation including requirements, specifications, V&V, risk documentation, traceability, labeling inputs, and release evidence.
• Participate in design reviews and assess product and software changes for quality and regulatory impact.
• Support global regulatory submissions and post-market regulatory activities.
• Contribute to CAPA, PMS, validation, supplier control, audit readiness, document control, and change control.
• Serve as Risk Manager for assigned medical device software products.
• Establish and maintain Risk Management Plans and Files per ISO 14971:2019.
• Facilitate hazard identification, risk analysis, risk evaluation, risk controls, verification of risk control effectiveness, and residual risk evaluation.
• Integrate risk management with the software lifecycle including IEC 62304, cybersecurity, usability engineering, CAPA, complaints, PMS, and design changes.
• AI & QARA Automation: promote AI-enabled regulatory workflows with verification and human oversight.

Skills

Quality Assurance

Regulatory Affairs

Risk management

Medical device software

SaMD

Regulatory submissions

Education

Bachelor's or Master’s in engineering/science

ISO 14971 risk management 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 blends QA/regulatory work with product risk management, collaborating with global teams to meet FDA, ISO, and IEC requirements across the lifecycle.

You will drive modernization of QARA processes, explore AI- and automation-enabled workflows, and ensure proper verification and human oversight