Senior QARA & Product Risk Manager (SaMD)

Topcon Healthcare; Florida; On-site; USD 100,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

401(k) plan with employer match

Tuition reimbursement

Paid holidays

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 focuses roughly 50% QARA and 50% product risk management, collaborating with global teams to ensure compliance with FDA QMSR/21 CFR 820, ISO 13485, ISO 14971, IEC 62304, and related standards.

Qualifications

• 5+ years of relevant experience in medical device Quality Assurance, Regulatory Affairs, risk management, medical device software, or a closely related regulated field.
• Strong knowledge of medical device regulations and standards, particularly FDA requirements, FDA QMSR / 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304.
• Experience with SaMD or software-containing medical devices, design controls, DHF/technical documentation, V&V, traceability, CAPA, PMS, audits, and/or regulatory submissions.
• Practical experience with medical-device risk management, including risk analysis, risk controls, verification evidence, and Risk Management Reports.
• Strong analytical, documentation, and technical-writing skills.
• Professional fluency in written and spoken English.
• Ability to work independently and effectively with global cross-functional teams.

Responsibilities

• Support the development and continuous improvement of our Quality Management System in accordance with applicable requirements, including FDA QMSR / 21 CFR Part 820 and ISO 13485.
• Support design controls and maintain DHF and technical documentation, including requirements, specifications, V&V evidence, 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 activities.

Skills

Quality Assurance

Regulatory Affairs

Risk Management

Medical Device Software

Regulatory Submissions

V&V

Education

Biomedical Engineering

Software Engineering

Computer Science

Health Technology

Life Sciences

Quality Engineering

Regulatory Affairs

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 focuses roughly 50% QARA and 50% product risk management, collaborating with global teams to ensure compliance with FDA QMSR/21 CFR 820, ISO 13485, ISO 14971, IEC 62304, and related standards.