Senior Quality Assurance and Regulatory Affairs, Risk Manager

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🔥 1 minute ago

🐊 Florida, New Jersey, +2 more states – Remote

🐊 Florida – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote 🍂 Massachusetts – Remote

💵 $100k - $120k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Topcon Positioning Systems

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1001 - 5000 employees

Founded 1932

🏗️ Construction

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🏭 Manufacturing

Construction • Logistics • Manufacturing

Topcon Positioning Systems is a company that operates in two main business domains: Positioning and Healthcare. It provides productivity and workflow automation solutions using precision positioning and data technologies for the global construction, geospatial, and agriculture markets. Additionally, Topcon Healthcare offers advanced imaging, diagnostic solutions, and intelligent data technology to improve diagnosis and treatment in eyecare. The company focuses on empowering its customers with innovative technologies that enhance overall efficiency and effectiveness in their respective fields.

📋 Description

• 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

• 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

• 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

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