Senior Quality Assurance & Regulatory Affairs (QARA) Specialist / Risk Manager

Topcon Positioning Systems•Remote (NJ-US), MA

8d•$100,000 - $120,000

About The Position

Topcon Healthcare is seeking an experienced Senior Quality Assurance & Regulatory Affairs (QARA) Specialist / Risk Manager to support medical device software and digital health products. This dual role is approximately 50% QARA and 50% product risk management, working with global Product, Engineering, Clinical, Cybersecurity, Usability, and QARA teams to ensure products meet applicable quality, regulatory, and safety requirements throughout their lifecycle. The position is based in the United States Eastern Time Zone to support collaboration with international teams. The role also helps modernize QARA by identifying ways to use AI and automation in regulatory and quality workflows, with appropriate controls, verification, and human oversight. Areas of potential automation include DHF and technical-documentation completeness checks, requirements/risk/evidence traceability, identification of missing or inconsistent regulatory evidence, CAPA and PMS data analysis, and audit evidence preparation.

Requirements

At least 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.
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.
Curiosity about applying AI to QARA processes and risk management, with understanding of where expert human judgment and oversight remain essential.

Nice To Haves

Training or demonstrated expertise in ISO 14971 risk management.
Additional experience or education in AI, automation, data science, or digital quality systems.
Comfort applying AI, automation, data analytics, or digital tools in regulated environments.

Responsibilities

Support the development and continuous improvement of the 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.
Serve as Risk Manager for assigned medical device software products.
Establish and maintain Risk Management Plans and Risk Management Files in accordance with 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.
Identify opportunities to apply AI and automation to QARA and risk-management workflows.
Ensure AI-assisted workflows have appropriate verification, quality controls, and human oversight, particularly for safety or regulatory judgments.