Senior Quality Assurance and Regulatory Affairs, Risk Manager

Topcon Positioning Systems

. Support development and continuous improvement of the Quality Management System in accordance with FDA QMSR / 21 CFR Part 820 and ISO 13485 .

Posted 11/3/2026full-timeRemote • United StatesSenior💰 $100,000 - $120,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems, regulatory compliance, and risk management for medical devices, with a strong focus on FDA and ISO standards. Proficient in technical documentation, design controls, and leveraging AI and automation to enhance quality workflows.

Highest-signal resume keywords

Quality Management System DevelopmentFDA QMSR / 21 CFR Part 820ISO 13485 ComplianceRisk Management According to ISO 14971Medical Device Software Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsDesign ControlsVerification and Validation (V&V)Technical DocumentationRisk AnalysisCAPA ManagementPMS ActivitiesAudit ReadinessTraceabilityChange Control

Soft Skills

Analytical SkillsTechnical WritingIndependent WorkCross-Functional CollaborationEffective Communication

Tools & Technologies

AI ApplicationsAutomation ToolsData AnalyticsDigital Quality Systems

Certifications & Qualifications

ISO 14971 Training

Industry Keywords

Medical Device Quality AssuranceSaMDIEC 62304Risk Management ReportsHazard Identification

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

Support development and continuous improvement of the Quality Management System in accordance with 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
Serve as Risk Manager for assigned medical device software products
Establish and maintain Risk Management Plans and Risk Management Files according to 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, cybersecurity, usability engineering, CAPA, complaints, PMS, and design changes
Identify opportunities to use AI and automation to improve regulatory and quality workflows
Ensure AI-assisted workflows have appropriate verification, quality controls, and human oversight

Requirements

What you’ll need

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 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
Comfort applying AI, automation, data analytics, or digital tools in regulated environments
Bachelor's or master's degree in biomedical engineering, software engineering, computer science, health technology, life sciences, quality engineering, regulatory affairs, or a related technical/scientific discipline; equivalent relevant professional experience may also be considered
Training or demonstrated expertise in ISO 14971 risk management is strongly preferred
Additional experience or education in AI, automation, data science, or digital quality systems is an advantage

Benefits

Comp & perks

Eligibility for a 5% annual bonus
Medical insurance
Dental insurance
Vision insurance
Life insurance
Disability insurance
Tax-saving spending accounts
401(k) plan with employer match
Tuition reimbursement
Paid company holidays
Paid personal time off
Paid sick time
Flexible paid time off policy for salaried employees
Comprehensive benefits package for employees working at least 30 hours per week